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Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00048542
First received: November 1, 2002
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
Results First Received: December 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Juvenile Idiopathic
Interventions: Biological: Double-Blind Adalimumab/Placebo + MTX
Biological: Double-Blind Adalimumab/Placebo
Drug: OLE BSA Adalimumab +/- MTX
Drug: OLE FD Adalimumab +/- MTX

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 31 sites between 19 September 2002 and 13 January 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 171 participants entered the Open-Label Lead-In (OL-LI) phase and received adalimumab. Of these 171 participants, 160 participants completed the OL-LI phase, and 133 participants entered the 32-week Double-Blind Phase (75 in the MTX stratum; 58 in the non-MTX stratum) and were randomized to adalimumab or placebo.

Reporting Groups
  Description
Double-Blind Adalimumab + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Placebo + MTX

Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.

MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Double-Blind Placebo Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Open-Label Extension BSA Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
Open-Label Extension BSA Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
Open-Label Extension FD Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Open-Label Extension FD Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.

Participant Flow for 3 periods

 Period 1:   Double-Blind Phase
    Double-Blind Adalimumab + MTX     Double-Blind Placebo + MTX     Double-Blind Adalimumab     Double-Blind Placebo     Open-Label Extension BSA Adalimumab + MTX     Open-Label Extension BSA Adalimumab     Open-Label Extension FD Adalimumab + MTX     Open-Label Extension FD Adalimumab  
STARTED     38 [1]   37     30     28     0     0     0     0  
COMPLETED     35     36     29     28     0     0     0     0  
NOT COMPLETED     3     1     1     0     0     0     0     0  
Withdrawal by Subject                 0                 1                 0                 0                 0                 0                 0                 0  
Protocol Violation                 0                 0                 1                 0                 0                 0                 0                 0  
Sponsor request or decision                 2                 0                 0                 0                 0                 0                 0                 0  
Randomized in error                 1                 0                 0                 0                 0                 0                 0                 0  
[1] For all groups, started indicates when the subjects entered the double-blind treatment phase.

Period 2:   Open-Label Extension BSA Phase
    Double-Blind Adalimumab + MTX     Double-Blind Placebo + MTX     Double-Blind Adalimumab     Double-Blind Placebo     Open-Label Extension BSA Adalimumab + MTX     Open-Label Extension BSA Adalimumab     Open-Label Extension FD Adalimumab + MTX     Open-Label Extension FD Adalimumab  
STARTED     0     0     0     0     71     57     0     0  
COMPLETED     0     0     0     0     59     47     0     0  
NOT COMPLETED     0     0     0     0     12     10     0     0  
Withdrawal by Subject                 0                 0                 0                 0                 3                 6                 0                 0  
Protocol Violation                 0                 0                 0                 0                 0                 1                 0                 0  
Sponsor request or decision                 0                 0                 0                 0                 5                 1                 0                 0  
Adverse Event                 0                 0                 0                 0                 1                 1                 0                 0  
Lack of Efficacy                 0                 0                 0                 0                 3                 1                 0                 0  

Period 3:   Open-Label Extension Fixed Dose Phase
    Double-Blind Adalimumab + MTX     Double-Blind Placebo + MTX     Double-Blind Adalimumab     Double-Blind Placebo     Open-Label Extension BSA Adalimumab + MTX     Open-Label Extension BSA Adalimumab     Open-Label Extension FD Adalimumab + MTX     Open-Label Extension FD Adalimumab  
STARTED     0     0     0     0     0     0     59     47  
COMPLETED     0     0     0     0     0     0     37     25  
NOT COMPLETED     0     0     0     0     0     0     22     22  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 6                 3  
Protocol Violation                 0                 0                 0                 0                 0                 0                 1                 1  
Sponsor request or decision                 0                 0                 0                 0                 0                 0                 6                 7  
Adverse Event                 0                 0                 0                 0                 0                 0                 2                 2  
Lack of Efficacy                 0                 0                 0                 0                 0                 0                 2                 1  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 5                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Double-Blind Adalimumab + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Placebo + MTX

Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.

MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Double-Blind Placebo Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Total Total of all reporting groups

Baseline Measures
    Double-Blind Adalimumab + MTX     Double-Blind Placebo + MTX     Double-Blind Adalimumab     Double-Blind Placebo     Total  
Number of Participants  
[units: participants]
 		  38     37     30     28     133  
Age [1]
[units: years]
Mean ± Standard Deviation 		  11.7  ± 3.29     10.8  ± 3.36     11.1  ± 4.13     11.3  ± 3.77     11.2  ± 3.64  
Gender [2]
[units: Participants]
 		         
Female     30     30     23     20     103  
Male     8     7     7     8     30  
[1] Age for participants in the Double-Blind Phase only.
[2] Numbers represent participants in the Double-Blind Phase only.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase   [ Time Frame: Week 16 to Week 48 (32 weeks) ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase   [ Time Frame: Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase   [ Time Frame: Week 16 to Week 48 (32 Weeks) ]
  Show Outcome Measure 3

4.  Secondary:   Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum   [ Time Frame: Week 16 to Week 48 (32 weeks) ]
  Show Outcome Measure 4

5.  Secondary:   Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum   [ Time Frame: Week 16 to Week 48 (32 weeks) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase   [ Time Frame: Week 48 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]
  Show Outcome Measure 10

11.  Secondary:   Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase   [ Time Frame: Baseline and Week 48 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Open-Label Lead-In Phase Baseline ]
  Show Outcome Measure 12

13.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Week 56 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase   [ Time Frame: Week 104 ]
  Show Outcome Measure 14

15.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Baseline ]
  Show Outcome Measure 15

16.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Week 48 ]
  Show Outcome Measure 16

17.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Week 112 ]
  Show Outcome Measure 17

18.  Secondary:   Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase   [ Time Frame: Final Visit (up to 224 weeks of OLE FD phase) ]
  Show Outcome Measure 18

19.  Other Pre-specified:   Baseline Measure: Gender, Female/Male - OLE BSA Phase   [ Time Frame: Baseline OLE BSA Phase ]
  Show Outcome Measure 19

20.  Other Pre-specified:   Baseline Measure: Age Continuous - OLE BSA Phase   [ Time Frame: Baseline OLE BSA Phase ]
  Show Outcome Measure 20

21.  Other Pre-specified:   Baseline Measure: Gender, Female/Male - OLE FD Phase   [ Time Frame: Baseline OLE FD Phase ]
  Show Outcome Measure 21

22.  Other Pre-specified:   Baseline Measure: Age Continuous - OLE FD Phase   [ Time Frame: Baseline OLE FD Phase ]
  Show Outcome Measure 22


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame DB Phase - Week 16 to 48 (32 Weeks), Open-Label Extension BSA Phase - OLE BSA Baseline to Week 136 (136 weeks), Open-Label Extension FD Phase - OLE FD Baseline to Final Visit (up to 224 weeks)* *Last observation of each subject in FD population.
Additional Description No text entered.

Reporting Groups
  Description
Double-Blind Adalimumab + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Placebo + MTX Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
Double-Blind Adalimumab Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Double-Blind Placebo Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
Open-Label Extension BSA Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
Open-Label Extension BSA Adalimumab Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
Open-Label Extension FD Adalimumab + MTX Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
Open-Label Extension FD Adalimumab Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.

Serious Adverse Events
    Double-Blind Adalimumab + MTX     Double-Blind Placebo + MTX     Double-Blind Adalimumab     Double-Blind Placebo     Open-Label Extension BSA Adalimumab + MTX     Open-Label Extension BSA Adalimumab     Open-Label Extension FD Adalimumab + MTX     Open-Label Extension FD Adalimumab  
Total, serious adverse events                  
# participants affected / at risk     3/38 (7.89%)     2/37 (5.41%)     1/30 (3.33%)     0/28 (0.00%)     13/71 (18.31%)     9/57 (15.79%)     7/59 (11.86%)     10/47 (21.28%)  
Cardiac disorders                  
Pericarditis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Eye disorders                  
Retinal detachment * 1                
# participants affected / at risk     0/38 (0.00%)     1/37 (2.70%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Gastrointestinal disorders                  
Gastroduodenitis * 1                
# participants affected / at risk     0/38 (0.00%)     1/37 (2.70%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Vomiting * 1                
# participants affected / at risk     1/38 (2.63%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Abdominal pain * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Haematochezia * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Malabsorption * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Infections and infestations                  
Appendicitis * 1                
# participants affected / at risk     1/38 (2.63%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Urinary tract infection * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     1/30 (3.33%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Bronchopneumonia * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Herpes zoster * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Pharyngitis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Viral infection * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Cervicitis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
Injury, poisoning and procedural complications                  
Injury * 1                
# participants affected / at risk     1/38 (2.63%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Joint dislocation * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Investigations                  
Laboratory test abnormal * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
Metabolism and nutrition disorders                  
Diabetic ketoacidosis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
Musculoskeletal and connective tissue disorders                  
Arthritis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     2/71 (2.82%)     0/57 (0.00%)     4/59 (6.78%)     7/47 (14.89%)  
Joint contracture * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Juvenile arthritis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     5/71 (7.04%)     1/57 (1.75%)     1/59 (1.69%)     1/47 (2.13%)  
Osteoarthritis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Knee Deformity * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     1/47 (2.13%)  
Osteochondrosis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Rheumatoid arthritis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
Spondylolisthesis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Tendon disorder * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Tendonitis * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
Nervous system disorders                  
Hydrocephalus * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     0/57 (0.00%)     0/59 (0.00%)     0/47 (0.00%)  
Speech disorder * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Pregnancy, puerperium and perinatal conditions                  
Abortion * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Abortion spontaneous * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Psychiatric disorders                  
Bipolar disorder * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Psychotic disorder * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Reproductive system and breast disorders                  
Breast enlargement * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Respiratory, thoracic and mediastinal disorders                  
Adenoidal hypertrophy * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     2/57 (3.51%)     0/59 (0.00%)     0/47 (0.00%)  
Nasal septum deviation * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     1/57 (1.75%)     0/59 (0.00%)     0/47 (0.00%)  
Tonsillar hypertrophy * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     1/71 (1.41%)     2/57 (3.51%)     0/59 (0.00%)     0/47 (0.00%)  
Skin and subcutaneous tissue disorders                  
Acne * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     0/59 (0.00%)     1/47 (2.13%)  
Surgical and medical procedures                  
Abortion induced * 1                
# participants affected / at risk     0/38 (0.00%)     0/37 (0.00%)     0/30 (0.00%)     0/28 (0.00%)     0/71 (0.00%)     0/57 (0.00%)     1/59 (1.69%)     0/47 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 7.0, 12.1 OLE




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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00048542     History of Changes
Other Study ID Numbers: DE038
Study First Received: November 1, 2002
Results First Received: December 7, 2009
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health and Consumption
Slovakia: State Institute for Drug Control