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

This study has been completed.
Sponsor:
Information provided by:
4SC AG
ClinicalTrials.gov Identifier:
NCT01010581
First received: November 9, 2009
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: SC12267 (4SC-101)
Drug: Placebo
Drug: Methotrexate
Drug: Folic Acid
Phase 2

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

Resource links provided by NLM:


Further study details as provided by 4SC AG:

Primary Outcome Measures:
  • Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC12267 (4SC-101) + Methotrexate Drug: SC12267 (4SC-101)
oral administration
Drug: Methotrexate
oral administration
Drug: Folic Acid
oral administration
Placebo Comparator: Placebo + Methotrexate Drug: Placebo
oral administration
Drug: Methotrexate
oral administration
Drug: Folic Acid
oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010581

Locations
Bulgaria
MHAT "Kaspela" Department of Rheumatology
Plovdiv, Bulgaria
UMHAT "Sveti Ivan Rilski"
Sofia, Bulgaria
Diagnostic Consulting Centre "Sv. Anna"
Sofia, Bulgaria
Military Medical Academy
Sofia, Bulgaria
National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
Sofia, Bulgaria
Czech Republic
Rheumatology Outpatient Clinic
Hlučín, Czech Republic
Institute of Rheumatology
Praha, Czech Republic
Diagnostic Center Mediscan
Praha 11, Czech Republic
Poland
Centrum Miriada, Prywatny Gabinet Specjalistyczny
Białystok, Poland
Mazowieckie Centrum Badań Klinicznych s.c.
Grodzisk Mazowiecki, Poland
Śląskie Centrum Osteoporozy
Katowice, Poland
Specjalistyczny Ośrodek ALL-MED
Kraków, Poland
Prof. Dr Hab. n. m. Leszek Szczepański
Lublin, Poland
NZOZ Reumed
Lublin, Poland
Poznański Ośrodek Medyczny NOVAMED
Poznań, Poland
Wojewódzki Szpital Reumatologiczny
Sopot, Poland
NZOZ "Nasz Lekarz"
Toruń, Poland
Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
Warszawa, Poland
Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
Warszawa, Poland
NZOZ Materia Medica
Wrocław, Poland
Romania
SC Duomedical
Bucharest, Romania
Clinic Hospital Sf. Maria
Bucharest, Romania
SC Ianuli Med Consult
Bucharest, Romania
Emergency Hospital "Prof. Dr. Gerota"
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, Romania
Sponsors and Collaborators
4SC AG
Investigators
Principal Investigator: Stanisław Sierakowski, Prof. MD Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
  More Information

No publications provided by 4SC AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01010581     History of Changes
Other Study ID Numbers: SC12267-5-2009
Study First Received: November 9, 2009
Last Updated: February 29, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by 4SC AG:
Rheumatoid Arthritis
SC12267
4SC-101
Methotrexate
Phase II

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Folic Acid
Vitamin B Complex
Methotrexate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 21, 2014