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CompletedNCT01010581COMPONENTUpdated Mar 1, 2012

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

A Phase 2 interventional study of SC12267 (4SC-101) and Placebo in Rheumatoid Arthritis, sponsored by 4SC AG. Completed at 27 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-01.

Sponsored by 4SC AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
266
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid Arthritis
  • SC12267
  • 4SC-101
  • Methotrexate
  • Phase II
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 266 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

4SC AG is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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:

    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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
266 participants (actual)

Study arms

  • Experimental
    SC12267 (4SC-101) + Methotrexate

    Drug: SC12267 (4SC-101) · Drug: Methotrexate · Drug: Folic Acid

  • Placebo comparator
    Placebo + Methotrexate

    Drug: Placebo · Drug: Methotrexate · Drug: Folic Acid

Interventions

  • DrugSC12267 (4SC-101)

    oral administration

  • DrugPlacebo

    oral administration

  • DrugMethotrexate

    oral administration

  • DrugFolic Acid

    oral administration

06

What researchers measure

Primary outcomes

  1. Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA

    Time frame: 13 weeks

Secondary outcomes

  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

07

Study locations

27 sites
  • MHAT "Kaspela" Department of Rheumatology
    Plovdiv, Bulgaria
  • Diagnostic Consulting Centre "Sv. Anna"
    Sofia, Bulgaria
  • Military Medical Academy
    Sofia, Bulgaria
  • National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
    Sofia, Bulgaria
  • UMHAT "Sveti Ivan Rilski"
    Sofia, Bulgaria
  • Rheumatology Outpatient Clinic
    Hlučín, Czech Republic
  • Diagnostic Center Mediscan
    Praha 11, Czech Republic
  • Institute of Rheumatology
    Praha, Czech Republic
  • 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
  • NZOZ Reumed
    Lublin, Poland
  • Prof. Dr Hab. n. m. Leszek Szczepański
    Lublin, Poland
  • Poznański Ośrodek Medyczny NOVAMED
    Poznań, Poland
  • Wojewódzki Szpital Reumatologiczny
    Sopot, Poland
  • NZOZ "Nasz Lekarz"
    Toruń, Poland
  • Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
    Warszawa, Poland
  • Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
    Warszawa, Poland
  • NZOZ Materia Medica
    Wrocław, Poland
  • Clinic Hospital Sf. Maria
    Bucharest, Romania
  • Emergency Hospital "Prof. Dr. Gerota"
    Bucharest, Romania
  • SC Duomedical
    Bucharest, Romania
  • SC Ianuli Med Consult
    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
08

References and documents

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. PubMed 31621054 ↗
  • 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. PubMed 20413687 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01010581
Lead sponsor
4SC AG
First posted
Nov 10, 2009
Start date
Nov 2009
Primary completion
Apr 2011
Completion
Jul 2011
Last update
Mar 1, 2012

Study contacts

Stanisław Sierakowski, Prof. MD
principal investigator · Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
View the source record on ClinicalTrials.gov ↗

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