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

4SC AG27 sites in 4 countries266 target enrollmentNovember 2009

ConditionsRheumatoid Arthritis

InterventionsFolic Acid SC12267 (4SC-101)Methotrexate Placebo

DrugsSC12267 (4SC-101)Placebo Methotrexate Folic Acid

Overview

Phase: Phase 2
Intervention: Folic Acid
Conditions: Rheumatoid Arthritis
Sponsor: 4SC AG
Enrollment: 266
Locations: 27
Primary Endpoint: Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

4SC AG

Eligibility Criteria

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

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

Arms & Interventions

Placebo + Methotrexate

Intervention: Folic Acid

SC12267 (4SC-101) + Methotrexate

Intervention: SC12267 (4SC-101)

SC12267 (4SC-101) + Methotrexate

Intervention: Methotrexate

SC12267 (4SC-101) + Methotrexate

Intervention: Folic Acid

Placebo + Methotrexate

Intervention: Placebo

Placebo + Methotrexate

Intervention: Methotrexate

Outcomes

Primary Outcomes

Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA

Time Frame: 13 weeks

Secondary Outcomes

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)