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

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:

    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 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.

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

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.

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