SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from Rheumatoid Arthritis.

Official Title
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A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SC12267 (4SC-101)
* Drug: Placebo
* Drug: Methotrexate
* Drug: Folic Acid


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Patients with active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA DAS28(ESR) ≥ 4.5 (DAS28 formula with 4 variables using ESR) Patients who have received weekly doses of MTX (10-25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and who have received a stable MTX dose of 10-25 mg/week without any change in route or change in folic acid supplementation for at least 6 weeks prior to Day 1 dosing Patients may receive up to 10 mg/day of oral prednisolone or steroid equivalent. Dose must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements Main Exclusion Criteria: Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA Patients who have received any of the following treatments must abide by the indicated washout period: Leflunomide requires a 6 month washout period prior to Day 1 dosing Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing Parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing Receipt of the following drugs within 4 weeks prior to dosing: Sulfasalazine Hydroxychloroquine Use of corticosteroids > 10 mg/day

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC12267 (4SC-101) + Methotrexate<br> | Drug: SC12267 (4SC-101)<br>* oral administration<br>Drug: Methotrexate<br>* oral administration<br>Drug: Folic Acid<br>* oral administration<br>|
| Placebo Comparator: Placebo + Methotrexate<br> | Drug: Placebo<br>* oral administration<br>Drug: Methotrexate<br>* oral administration<br>Drug: Folic Acid<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA |  | 13 weeks | 
| Evaluation of the plasma concentration (trough value) of SC12267 (4SC-101) after once daily application in combination with methotrexate after once weekly administration. |  | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, SC12267, 4SC-101, Methotrexate, Phase II