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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: SC12267 (4SC-101); Drug: Methotrexate; Drug: Folic Acid

• Registration Number: NCT01010581
• Lead Sponsor: 4SC AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Methotrexate	Placebo	-
Placebo + Methotrexate	Methotrexate	-
Placebo + Methotrexate	Folic Acid	-
SC12267 (4SC-101) + Methotrexate	SC12267 (4SC-101)	-
SC12267 (4SC-101) + Methotrexate	Methotrexate	-
SC12267 (4SC-101) + Methotrexate	Folic Acid	-

Primary Outcome Measures

Name	Time	Method
Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA	13 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (27)

UMHAT "Sveti Ivan Rilski"; 🇧🇬 Sofia, Bulgaria

Śląskie Centrum Osteoporozy; 🇵🇱 Katowice, Poland

Wojewódzki Szpital Reumatologiczny; 🇵🇱 Sopot, Poland

Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów; 🇵🇱 Warszawa, Poland

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic; 🇧🇬 Sofia, Bulgaria

Rheumatology Outpatient Clinic; 🇨🇿 Hlučín, Czech Republic

Specjalistyczny Ośrodek ALL-MED; 🇵🇱 Kraków, Poland

Poznański Ośrodek Medyczny NOVAMED; 🇵🇱 Poznań, Poland

NZOZ "Nasz Lekarz"; 🇵🇱 Toruń, Poland

Emergency Hospital "Prof. Dr. Gerota"; 🇷🇴 Bucharest, Romania

SC Duomedical; 🇷🇴 Bucharest, Romania

SC Ianuli Med Consult; 🇷🇴 Bucharest, Romania

NZOZ Materia Medica; 🇵🇱 Wrocław, Poland

Clinic Hospital Sf. Maria; 🇷🇴 Bucharest, Romania

County Hospital Cluj - Rheumatology clinic; 🇷🇴 Cluj Napoca, Romania

Private Practice Prof. Dr. Mioara Banciu; 🇷🇴 Timisoara, Romania

Diagnostic Center Mediscan; 🇨🇿 Praha 11, Czech Republic

Institute of Rheumatology; 🇨🇿 Praha, Czech Republic

NZOZ Reumed; 🇵🇱 Lublin, Poland

MHAT "Kaspela" Department of Rheumatology; 🇧🇬 Plovdiv, Bulgaria

Diagnostic Consulting Centre "Sv. Anna"; 🇧🇬 Sofia, Bulgaria

Centrum Miriada, Prywatny Gabinet Specjalistyczny; 🇵🇱 Białystok, Poland

Mazowieckie Centrum Badań Klinicznych s.c.; 🇵🇱 Grodzisk Mazowiecki, Poland

Prof. Dr Hab. n. m. Leszek Szczepański; 🇵🇱 Lublin, Poland

Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.; 🇵🇱 Warszawa, Poland

Clinical County Hospital of Targoviste; 🇷🇴 Targoviste, Dambovita, Romania