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
Overview
- Phase
- Phase 1
- Intervention
- ATN-103
- Conditions
- Active Rheumatoid Arthritis
- Sponsor
- Ablynx, a Sanofi company
- Enrollment
- 252
- Locations
- 1
- Primary Endpoint
- American College of Rheumatology (ACR) 20 response at week 16
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
Intervention: ATN-103
Treatment Group 1
ATN-103 10 mg every 4 weeks until week 12
Intervention: Methotrexate
Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
Intervention: ATN-103
Treatment Group 2
ATN-103 10 mg every 8 weeks until week 12
Intervention: Methotrexate
Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
Intervention: ATN-103
Treatment Group 3
ATN-103 30 mg every 4 weeks until week 12
Intervention: Methotrexate
Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
Intervention: ATN-103
Treatment Group 4
ATN-103 80 mg every 4 weeks until week 12
Intervention: Methotrexate
Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
Intervention: ATN-103
Treatment Group 5
ATN-103 80 mg every 8 weeks until week 12
Intervention: Methotrexate
Treatment Group 6
Placebo every 4 weeks
Intervention: Placebo
Treatment Group 6
Placebo every 4 weeks
Intervention: Methotrexate
Outcomes
Primary Outcomes
American College of Rheumatology (ACR) 20 response at week 16
Time Frame: 6 months
Secondary Outcomes
- 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)