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

Phase 1

Completed

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: ATN-103; Drug: Placebo; Drug: Methotrexate

• Registration Number: NCT00959036
• Lead Sponsor: Ablynx, a Sanofi company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-15
• Disposition First Submitted QC: 2013-01-15
• Disposition First Posted: 2013-01-24
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

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

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Exclusion Criteria

• Any significant health problem other than rheumatoid arthritis
• Any clinically significant laboratory abnormalities
• Any prior use of B cell-depleting therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	ATN-103	ATN-103 10 mg every 4 weeks until week 12
Treatment Group 1	Methotrexate	ATN-103 10 mg every 4 weeks until week 12
Treatment Group 2	ATN-103	ATN-103 10 mg every 8 weeks until week 12
Treatment Group 3	ATN-103	ATN-103 30 mg every 4 weeks until week 12
Treatment Group 3	Methotrexate	ATN-103 30 mg every 4 weeks until week 12
Treatment Group 4	ATN-103	ATN-103 80 mg every 4 weeks until week 12
Treatment Group 5	ATN-103	ATN-103 80 mg every 8 weeks until week 12
Treatment Group 6	Methotrexate	Placebo every 4 weeks
Treatment Group 6	Placebo	Placebo every 4 weeks
Treatment Group 5	Methotrexate	ATN-103 80 mg every 8 weeks until week 12
Treatment Group 2	Methotrexate	ATN-103 10 mg every 8 weeks until week 12
Treatment Group 4	Methotrexate	ATN-103 80 mg every 4 weeks until week 12

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology (ACR) 20 response at week 16	6 months

Secondary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (1)

Investigational Site; 🇨🇭 Chur, Switzerland