Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, SC12267, 4SC-101, Methotrexate, Phase II
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.
Interventions
oral administration
DRUGPlacebo
oral administration
DRUGMethotrexate
oral administration
DRUGFolic Acid
oral administration
Sponsors
4SC AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: 1. Leflunomide requires a 6 month washout period prior to Day 1 dosing 2. Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing 3. Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing 4. Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing 5. 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: 1. Sulfasalazine 2. Hydroxychloroquine 3. Use of corticosteroids \> 10 mg/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA | 13 weeks |
Secondary
| Measure | 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 |
Countries
Bulgaria, Czechia, Poland, Romania
Outcome results
None listed