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

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ClinicalTrials.gov Identifier: NCT01010581
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : March 1, 2012
Sponsor:
Information provided by:
4SC AG

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : July 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA [ Time Frame: 13 weeks ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010581


Locations
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Sponsors and Collaborators
4SC AG
Investigators
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Principal Investigator: Stanisław Sierakowski, Prof. MD Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT01010581    
Other Study ID Numbers: SC12267-5-2009
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012
Keywords provided by 4SC AG:
Rheumatoid Arthritis
SC12267
4SC-101
Methotrexate
Phase II
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Folic Acid
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Hematinics
Vitamin B Complex
Vitamins
Micronutrients