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Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT00959036
First received: August 13, 2009
Last updated: January 28, 2013
Last verified: January 2013
History of Changes

August 13, 2009
January 28, 2013
September 2009
January 2011   (final data collection date for primary outcome measure)
American College of Rheumatology (ACR) 20 response at week 16 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959036 on ClinicalTrials.gov Archive Site
Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The number of swollen and tender joints [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Physician and patient global assessments of disease activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • ACR responses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • DAS28 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • EULAR [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health Outcome Assessments [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Active Rheumatoid Arthritis
  • Drug: ATN-103
    10 mg every 4 weeks until week 12
  • Drug: ATN-103
    10 mg every 8 weeks until week 12
  • Drug: ATN-103
    30 mg every 4 weeks until week 12
  • Drug: ATN-103
    80 mg every 4 weeks until week 12
  • Drug: ATN-103
    80 mg every 8 weeks until week 12
  • Drug: Placebo
    Placebo every 4 weeks
  • Drug: Methotrexate
  • Experimental: Treatment Group 1
    ATN-103 10 mg every 4 weeks until week 12
    Interventions:
    • Drug: ATN-103
    • Drug: Methotrexate
  • Experimental: Treatment Group 2
    ATN-103 10 mg every 8 weeks until week 12
    Interventions:
    • Drug: ATN-103
    • Drug: Methotrexate
  • Experimental: Treatment Group 3
    ATN-103 30 mg every 4 weeks until week 12
    Interventions:
    • Drug: ATN-103
    • Drug: Methotrexate
  • Experimental: Treatment Group 4
    ATN-103 80 mg every 4 weeks until week 12
    Interventions:
    • Drug: ATN-103
    • Drug: Methotrexate
  • Experimental: Treatment Group 5
    ATN-103 80 mg every 8 weeks until week 12
    Interventions:
    • Drug: ATN-103
    • Drug: Methotrexate
  • Placebo Comparator: Treatment Group 6
    Placebo every 4 weeks
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

Exclusion Criteria:

  • Any significant health problem other than rheumatoid arthritis
  • Any clinically significant laboratory abnormalities
  • Any prior use of B cell-depleting therapy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Hungary,   Russian Federation,   Serbia,   South Africa,   Switzerland
 
NCT00959036
3242K1-2000, B2271003
Yes
Ablynx
Ablynx
Not Provided
Study Director: Josefin-Beate Holz, MD Ablynx
Ablynx
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP