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

Rheumatoid Arthritis Clinical Trial

— COMPONENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010581
• Other study ID #: SC12267-5-2009
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2009
• Last updated: February 29, 2012
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyRomania: National Medicines AgencyCzech Republic: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SC12267 (4SC-101)
oral administration
• Placebo
oral administration
• Methotrexate
oral administration
• Folic Acid
oral administration

Locations

Country	Name	City	State
Bulgaria	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
Czech Republic	Rheumatology Outpatient Clinic	Hlucín
Czech Republic	Institute of Rheumatology	Praha
Czech Republic	Diagnostic Center Mediscan	Praha 11
Poland	Centrum Miriada, Prywatny Gabinet Specjalistyczny	Bialystok
Poland	Mazowieckie Centrum Badan Klinicznych s.c.	Grodzisk Mazowiecki
Poland	Slaskie Centrum Osteoporozy	Katowice
Poland	Specjalistyczny Osrodek ALL-MED	Kraków
Poland	NZOZ Reumed	Lublin
Poland	Prof. Dr Hab. n. m. Leszek Szczepanski	Lublin
Poland	Poznanski Osrodek 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.	Warszawa
Poland	Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów	Warszawa
Poland	NZOZ Materia Medica	Wroclaw
Romania	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	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA		13 weeks	No
Secondary	Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA		13 weeks	Yes
Secondary	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	No