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

NCT ID: NCT01010581

Last Updated: 2012-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-07-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SC12267 (4SC-101) + Methotrexate

Group Type: EXPERIMENTAL

SC12267 (4SC-101)

Intervention Type: DRUG

oral administration

Methotrexate

Intervention Type: DRUG

oral administration

Folic Acid

Intervention Type: DRUG

oral administration

Placebo + Methotrexate

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral administration

Methotrexate

Intervention Type: DRUG

oral administration

Folic Acid

Intervention Type: DRUG

oral administration

Interventions

SC12267 (4SC-101)

oral administration

Intervention Type: DRUG

Placebo

oral administration

Intervention Type: DRUG

Methotrexate

oral administration

Intervention Type: DRUG

Folic Acid

oral administration

Intervention Type: DRUG

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

4SC AG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Stanisław Sierakowski, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland

Locations

MHAT "Kaspela" Department of Rheumatology

Plovdiv, , Bulgaria

Diagnostic Consulting Centre "Sv. Anna"

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic

Sofia, , Bulgaria

UMHAT "Sveti Ivan Rilski"

Sofia, , Bulgaria

Rheumatology Outpatient Clinic

Hlučín, , Czechia

Diagnostic Center Mediscan

Prague, , Czechia

Institute of Rheumatology

Prague, , Czechia

Centrum Miriada, Prywatny Gabinet Specjalistyczny

Bialystok, , Poland

Mazowieckie Centrum Badań Klinicznych s.c.

Grodzisk Mazowiecki, , Poland

Śląskie Centrum Osteoporozy

Katowice, , Poland

Specjalistyczny Ośrodek ALL-MED

Krakow, , Poland

NZOZ Reumed

Lublin, , Poland

Prof. Dr Hab. n. m. Leszek Szczepański

Lublin, , Poland

Poznański Ośrodek Medyczny NOVAMED

Poznan, , Poland

Wojewódzki Szpital Reumatologiczny

Sopot, , Poland

NZOZ "Nasz Lekarz"

Torun, , Poland

Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.

Warsaw, , Poland

Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów

Warsaw, , Poland

NZOZ Materia Medica

Wroclaw, , Poland

Clinic Hospital Sf. Maria

Bucharest, , Romania

Emergency Hospital "Prof. Dr. Gerota"

Bucharest, , Romania

SC Duomedical

Bucharest, , Romania

SC Ianuli Med Consult

Bucharest, , Romania

County Hospital Cluj - Rheumatology clinic

Cluj-Napoca, , Romania

Clinical County Hospital of Targoviste

Targoviste, Dambovita, , Romania

Private Practice Prof. Dr. Mioara Banciu

Timișoara, , Romania

Countries

Bulgaria; Czechia; Poland; Romania

References

Muehler A, Kohlhof H, Groeppel M, Vitt D. The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study. Drugs R D. 2019 Dec;19(4):351-366. doi: 10.1007/s40268-019-00286-z.

Reference Type: DERIVED

PMID: 31621054 (View on PubMed)

Kulkarni OP, Sayyed SG, Kantner C, Ryu M, Schnurr M, Sardy M, Leban J, Jankowsky R, Ammendola A, Doblhofer R, Anders HJ. 4SC-101, a novel small molecule dihydroorotate dehydrogenase inhibitor, suppresses systemic lupus erythematosus in MRL-(Fas)lpr mice. Am J Pathol. 2010 Jun;176(6):2840-7. doi: 10.2353/ajpath.2010.091227. Epub 2010 Apr 22.

Reference Type: DERIVED

PMID: 20413687 (View on PubMed)

Other Identifiers

SC12267-5-2009

Identifier Type: -

Identifier Source: org_study_id