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Rheumatoid ArthritisPhase 2COMPONENTNCT01010581

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

A Phase 2 study testing SC12267 (4SC-101), Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by 4SC AG at 27 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
SC12267 (4SC-101), Methotrexate and Folic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
266 participants
Where
27 sitesin 4 countries
Study dates
Nov 2009to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

Poland12 sites

  • Centrum Miriada, Prywatny Gabinet Specjalistyczny

    Bialystok

  • Mazowieckie Centrum Badań Klinicznych s.c.

    Grodzisk Mazowiecki

  • Śląskie Centrum Osteoporozy

    Katowice

  • Specjalistyczny Ośrodek ALL-MED

    Krakow

  • NZOZ Reumed

    Lublin

  • Prof. Dr Hab. n. m. Leszek Szczepański

    Lublin

  • Poznański Ośrodek Medyczny NOVAMED

    Poznan

  • Wojewódzki Szpital Reumatologiczny

    Sopot

  • NZOZ "Nasz Lekarz"

    Torun

  • Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.

    Warsaw

  • Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów

    Warsaw

  • NZOZ Materia Medica

    Wroclaw

Other trials in Poland

Romania7 sites

  • Clinic Hospital Sf. Maria

    Bucharest

  • Emergency Hospital "Prof. Dr. Gerota"

    Bucharest

  • SC Duomedical

    Bucharest

  • SC Ianuli Med Consult

    Bucharest

  • County Hospital Cluj - Rheumatology clinic

    Cluj-Napoca

  • Clinical County Hospital of Targoviste

    Targoviste, Dambovita

  • Private Practice Prof. Dr. Mioara Banciu

    Timișoara

Other trials in Romania

Bulgaria5 sites

  • MHAT "Kaspela" Department of Rheumatology

    Plovdiv

  • Diagnostic Consulting Centre "Sv. Anna"

    Sofia

  • Military Medical Academy

    Sofia

  • National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic

    Sofia

  • UMHAT "Sveti Ivan Rilski"

    Sofia

Other trials in Bulgaria

Czechia3 sites

  • Rheumatology Outpatient Clinic

    Hlučín

  • Diagnostic Center Mediscan

    Prague

  • Institute of Rheumatology

    Prague

Other trials in Czechia

About this study

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

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.

Being tested
SC12267 (4SC-101), Placebo, Methotrexate, Folic Acid
Keywords
Rheumatoid Arthritis, SC12267, 4SC-101, Methotrexate, Phase II
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC12267 (4SC-101)Drug

    oral administration

  • PlaceboDrug

    oral administration

  • MethotrexateDrug

    oral administration

  • Folic AcidDrug

    oral administration

Study groups in NCT01010581
Study groupRoleWhat they receive
SC12267 (4SC-101) + MethotrexateExperimentalNot described
Receives: Drug: SC12267 (4SC-101); Drug: Methotrexate; Drug: Folic Acid
Placebo + MethotrexatePlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Methotrexate; Drug: Folic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 13 weeks

Secondary outcomes (2)

  1. Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA

    Measured: 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.

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2011
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01010581
Sponsor's protocol ID
SC12267-5-2009
Acronym
COMPONENT
Status last verified
Feb 2012
First submitted
9 Nov 2009
Last updated
1 Mar 2012
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SC12267 (4SC-101), Methotrexate and Folic Acid in people with Rheumatoid Arthritis, run by 4SC AG at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Poland, Romania, Bulgaria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01010581, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2012.

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