SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (COMPONENT)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SC12267 (4SC-101)
Placebo
Methotrexate
Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, SC12267, 4SC-101, Methotrexate, Phase II
Eligibility 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:
- 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
Sites / Locations
- MHAT "Kaspela" Department of Rheumatology
- Diagnostic Consulting Centre "Sv. Anna"
- Military Medical Academy
- National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
- UMHAT "Sveti Ivan Rilski"
- Rheumatology Outpatient Clinic
- Diagnostic Center Mediscan
- Institute of Rheumatology
- Centrum Miriada, Prywatny Gabinet Specjalistyczny
- Mazowieckie Centrum Badań Klinicznych s.c.
- Śląskie Centrum Osteoporozy
- Specjalistyczny Ośrodek ALL-MED
- NZOZ Reumed
- Prof. Dr Hab. n. m. Leszek Szczepański
- Poznański Ośrodek Medyczny NOVAMED
- Wojewódzki Szpital Reumatologiczny
- NZOZ "Nasz Lekarz"
- Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
- Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
- NZOZ Materia Medica
- Clinic Hospital Sf. Maria
- Emergency Hospital "Prof. Dr. Gerota"
- SC Duomedical
- SC Ianuli Med Consult
- County Hospital Cluj - Rheumatology clinic
- Clinical County Hospital of Targoviste
- Private Practice Prof. Dr. Mioara Banciu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SC12267 (4SC-101) + Methotrexate
Placebo + Methotrexate
Arm Description
Outcomes
Primary Outcome Measures
Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
Secondary Outcome Measures
Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA
Evaluation of the plasma concentration (trough value) of SC12267 (4SC-101) after once daily application in combination with methotrexate after once weekly administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010581
Brief Title
SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
4SC AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, SC12267, 4SC-101, Methotrexate, Phase II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SC12267 (4SC-101) + Methotrexate
Arm Type
Experimental
Arm Title
Placebo + Methotrexate
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SC12267 (4SC-101)
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA
Time Frame
13 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanisław Sierakowski, Prof. MD
Organizational Affiliation
Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
MHAT "Kaspela" Department of Rheumatology
City
Plovdiv
Country
Bulgaria
Facility Name
Diagnostic Consulting Centre "Sv. Anna"
City
Sofia
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "Sveti Ivan Rilski"
City
Sofia
Country
Bulgaria
Facility Name
Rheumatology Outpatient Clinic
City
Hlučín
Country
Czech Republic
Facility Name
Diagnostic Center Mediscan
City
Praha 11
Country
Czech Republic
Facility Name
Institute of Rheumatology
City
Praha
Country
Czech Republic
Facility Name
Centrum Miriada, Prywatny Gabinet Specjalistyczny
City
Białystok
Country
Poland
Facility Name
Mazowieckie Centrum Badań Klinicznych s.c.
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Śląskie Centrum Osteoporozy
City
Katowice
Country
Poland
Facility Name
Specjalistyczny Ośrodek ALL-MED
City
Kraków
Country
Poland
Facility Name
NZOZ Reumed
City
Lublin
Country
Poland
Facility Name
Prof. Dr Hab. n. m. Leszek Szczepański
City
Lublin
Country
Poland
Facility Name
Poznański Ośrodek Medyczny NOVAMED
City
Poznań
Country
Poland
Facility Name
Wojewódzki Szpital Reumatologiczny
City
Sopot
Country
Poland
Facility Name
NZOZ "Nasz Lekarz"
City
Toruń
Country
Poland
Facility Name
Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
City
Warszawa
Country
Poland
Facility Name
Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
City
Warszawa
Country
Poland
Facility Name
NZOZ Materia Medica
City
Wrocław
Country
Poland
Facility Name
Clinic Hospital Sf. Maria
City
Bucharest
Country
Romania
Facility Name
Emergency Hospital "Prof. Dr. Gerota"
City
Bucharest
Country
Romania
Facility Name
SC Duomedical
City
Bucharest
Country
Romania
Facility Name
SC Ianuli Med Consult
City
Bucharest
Country
Romania
Facility Name
County Hospital Cluj - Rheumatology clinic
City
Cluj Napoca
Country
Romania
Facility Name
Clinical County Hospital of Targoviste
City
Targoviste, Dambovita
Country
Romania
Facility Name
Private Practice Prof. Dr. Mioara Banciu
City
Timisoara
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
31621054
Citation
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.
Results Reference
derived
PubMed Identifier
20413687
Citation
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.
Results Reference
derived
Learn more about this trial
SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis
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