Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Official Title
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Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

Conditions
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Active Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SBI-087
* Drug: SBI-087
* Drug: SBI-087
* Drug: SBI-087
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity Must be receiving a stable route and dose of methotrexate (up to 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

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> | Drug: SBI-087<br>* 200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate<br>|
| Experimental: Treatment Group 2<br> | Drug: SBI-087<br>* 200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate<br>|
| Experimental: Treatment Group 3<br> | Drug: SBI-087<br>* 200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate<br>|
| Experimental: Treatment Group 4<br> | Drug: SBI-087<br>* 200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate<br>|
| Placebo Comparator: Treatment Group 5<br> | Drug: Placebo<br>* Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response as measured by American College of Rheumatology criteria (ACR 20 response) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, seropositive, methotrexate