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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Active Rheumatoid Arthritis

Intervention / Treatment
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* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: ATN-103
* Drug: Placebo
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>ATN-103 10 mg every 4 weeks until week 12 | Drug: ATN-103<br>* 10 mg every 4 weeks until week 12<br>Drug: Methotrexate<br> <br> |
| Experimental: Treatment Group 2<br>ATN-103 10 mg every 8 weeks until week 12 | Drug: ATN-103<br>* 10 mg every 8 weeks until week 12<br>Drug: Methotrexate<br> <br> |
| Experimental: Treatment Group 3<br>ATN-103 30 mg every 4 weeks until week 12 | Drug: ATN-103<br>* 30 mg every 4 weeks until week 12<br>Drug: Methotrexate<br> <br> |
| Experimental: Treatment Group 4<br>ATN-103 80 mg every 4 weeks until week 12 | Drug: ATN-103<br>* 80 mg every 4 weeks until week 12<br>Drug: Methotrexate<br> <br> |
| Experimental: Treatment Group 5<br>ATN-103 80 mg every 8 weeks until week 12 | Drug: ATN-103<br>* 80 mg every 8 weeks until week 12<br>Drug: Methotrexate<br> <br> |
| Placebo Comparator: Treatment Group 6<br>Placebo every 4 weeks | Drug: Placebo<br>* Placebo every 4 weeks<br>Drug: Methotrexate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology (ACR) 20 response at week 16 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |