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Dosing Flexibility Study in Patients With Rheumatoid Arthritis (DoseFlex)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00580840
First received: December 21, 2007
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
Results First Received: December 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Certolizumab pegol
Other: Placebo

  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
The study started in December 2007 with subjects from Canada, France, and United States. The primary completion date occurred in December 2010, with study completion in March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Overall Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
CZP 400 mg and PLO + MTX Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
CZP 200 mg and PLO + MTX Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
PLO + MTX Placebo (PTO) + Methotrexate (MTX)

Participant Flow for 2 periods

 Period 1:   Run-in
    Overall     CZP 400 mg and PLO + MTX     CZP 200 mg and PLO + MTX     PLO + MTX  
STARTED     333 [1]   0     0     0  
COMPLETED     209 [2]   0     0     0  
NOT COMPLETED     124     0     0     0  
Adverse Event                 17                 0                 0                 0  
Lack of Efficacy                 93                 0                 0                 0  
Loss of Efficacy                 1                 0                 0                 0  
Lost to Follow-up                 4                 0                 0                 0  
Withdrawal by Subject                 5                 0                 0                 0  
Other: Per Sponsor Request                 2                 0                 0                 0  
Other: Did Not Meet Joint Count Criteria                 1                 0                 0                 0  
Other: Exclusionary Lab Value                 1                 0                 0                 0  
[1] 620 subjects were screened for the study with 333 being enrolled.
[2] Of the 209 randomized participants, 208 are in the Full Analysis Set (FAS).

Period 2:   Double-Blind
    Overall     CZP 400 mg and PLO + MTX     CZP 200 mg and PLO + MTX     PLO + MTX  
STARTED     0     70     70     69  
COMPLETED     0     63     61     54  
NOT COMPLETED     0     7     9     15  
Adverse Event                 0                 3                 4                 1  
Loss of Efficacy                 0                 1                 2                 10  
Lost to Follow-up                 0                 1                 0                 2  
Withdrawal by Subject                 0                 1                 2                 2  
Other: Discontinued Methotrexate                 0                 1                 0                 0  
Other: Forbidden Medication                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Run-in Overall Overall includes all 333 subjects that entered the Run-in period of the study

Baseline Measures
    Run-in Overall  
Number of Participants  
[units: participants]
 		  333  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     264  
>=65 years     69  
Age  
[units: years]
Mean ± Standard Deviation 		  54.2  ± 12.75  
Gender  
[units: participants]
 		 
Female     253  
Male     80  
Region of Enrollment  
[units: participants]
 		 
France     7  
United States     306  
Canada     20  



  Outcome Measures
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1.  Primary:   Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients
Measure Description ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)
Time Frame Baseline, Week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Since Non-Response Imputation (NRI) was used, all 333 subjects in the run-in period are included in this analysis

Reporting Groups
  Description
Run-in Overall Overall includes all 333 subjects that entered the Run-in period of the study

Measured Values
    Run-in Overall  
Number of Participants Analyzed  
[units: participants]
 		  333  
Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients  
[units: percentage of subjects]
 		  16.2  

No statistical analysis provided for Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 16 in All Patients



5.  Secondary:   Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 7

8.  Secondary:   DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 16 in All Patients   [ Time Frame: Week 16 ]
  Show Outcome Measure 8

9.  Secondary:   SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 16 in All Patients   [ Time Frame: Week 16 ]
  Show Outcome Measure 9

10.  Secondary:   CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 16 in All Patients   [ Time Frame: Week 16 ]
  Show Outcome Measure 10

11.  Secondary:   Ratio From Baseline in CRP (C-reactive Protein) Level at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 13

14.  Secondary:   Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in DAS28 (Disease Activity Score-28 Items) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 17

18.  Secondary:   DAS28 (Disease Activity Score-28 Items) Remission (DAS28 <2.6) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Week 34 ]
  Show Outcome Measure 18

19.  Secondary:   SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Week 34 ]
  Show Outcome Measure 19

20.  Secondary:   CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Week 34 ]
  Show Outcome Measure 20

21.  Secondary:   Ratio From Baseline in CRP (C-reactive Protein) Level at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) Score at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 22

23.  Secondary:   Change From Baseline in Fatigue Assessment Scale (FAS) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 24

25.  Secondary:   Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 26

27.  Secondary:   Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 30

31.  Secondary:   Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 32

33.  Secondary:   Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 33

34.  Secondary:   Change From Baseline in PAAP (Patient's Assessment of Arthritis Pain) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 34

35.  Secondary:   Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 35

36.  Secondary:   Median Time to Loss of ACR20 (American College of Rheumatology 20% Improvement) Response After Week 18 in Patients Randomized at Week 18.   [ Time Frame: Week 18 up to Week 34 ]
  Show Outcome Measure 36

37.  Other Pre-specified:   Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 16 in All Patients   [ Time Frame: Baseline, Week 16 ]
  Show Outcome Measure 37

38.  Other Pre-specified:   Ratio From Baseline in ESR (Erythrocyte Sedimentation Rate) Level at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 38

39.  Other Pre-specified:   Change From Baseline in PhGADA (Physician’s Global Assessment of Disease Activity) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 39

40.  Other Pre-specified:   Change From Baseline in TJC (Tender Joint Count) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 40

41.  Other Pre-specified:   Change From Baseline in SJC (Swollen Joint Count) at Week 34 in Patients Randomized at Week 18   [ Time Frame: Baseline, Week 34 ]
  Show Outcome Measure 41


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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
No text entered.  


Results Point of Contact:  
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00580840     History of Changes
Other Study ID Numbers: C87077, 2007-005267-10
Study First Received: December 21, 2007
Results First Received: December 14, 2011
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)