- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010581
SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (COMPONENT)
February 29, 2012 updated by: 4SC AG
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
266
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Plovdiv, Bulgaria
- MHAT "Kaspela" Department of Rheumatology
-
Sofia, Bulgaria
- Military Medical Academy
-
Sofia, Bulgaria
- Diagnostic Consulting Centre "Sv. Anna"
-
Sofia, Bulgaria
- National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
-
Sofia, Bulgaria
- UMHAT "Sveti Ivan Rilski"
-
-
-
-
-
Hlučín, Czech Republic
- Rheumatology Outpatient Clinic
-
Praha, Czech Republic
- Institute of Rheumatology
-
Praha 11, Czech Republic
- Diagnostic Center Mediscan
-
-
-
-
-
Białystok, Poland
- Centrum Miriada, Prywatny Gabinet Specjalistyczny
-
Grodzisk Mazowiecki, Poland
- Mazowieckie Centrum Badań Klinicznych s.c.
-
Katowice, Poland
- Slaskie Centrum Osteoporozy
-
Kraków, Poland
- Specjalistyczny Ośrodek ALL-MED
-
Lublin, Poland
- NZOZ Reumed
-
Lublin, Poland
- Prof. Dr Hab. n. m. Leszek Szczepański
-
Poznań, Poland
- Poznański Ośrodek Medyczny NOVAMED
-
Sopot, Poland
- Wojewódzki Szpital Reumatologiczny
-
Toruń, Poland
- NZOZ "Nasz Lekarz"
-
Warszawa, Poland
- Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
-
Warszawa, Poland
- Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
-
Wrocław, Poland
- NZOZ Materia Medica
-
-
-
-
-
Bucharest, Romania
- Clinic Hospital Sf. Maria
-
Bucharest, Romania
- Emergency Hospital "Prof. Dr. Gerota"
-
Bucharest, Romania
- SC Duomedical
-
Bucharest, Romania
- SC Ianuli Med Consult
-
Cluj Napoca, Romania
- County Hospital Cluj - Rheumatology clinic
-
Targoviste, Dambovita, Romania
- Clinical County Hospital of Targoviste
-
Timisoara, Romania
- Private Practice Prof. Dr. Mioara Banciu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
- Use of corticosteroids > 10 mg/day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo + Methotrexate
|
oral administration
oral administration
oral administration
|
Experimental: SC12267 (4SC-101) + Methotrexate
|
oral administration
oral administration
oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
Time Frame: 13 weeks
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA
Time Frame: 13 weeks
|
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.
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stanisław Sierakowski, Prof. MD, Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
March 1, 2012
Last Update Submitted That Met QC Criteria
February 29, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Micronutrients
- Vitamins
- Reproductive Control Agents
- Vitamin B Complex
- Hematinics
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Folic Acid
Other Study ID Numbers
- SC12267-5-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States