NCT01010581

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2009

Geographic Reach
4 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

November 9, 2009

Last Update Submit

February 29, 2012

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisSC122674SC-101MethotrexatePhase II

Outcome Measures

Primary Outcomes (1)

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

    13 weeks

Secondary Outcomes (2)

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

    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.

    13 weeks

Study Arms (2)

SC12267 (4SC-101) + Methotrexate

EXPERIMENTAL
Drug: SC12267 (4SC-101)Drug: MethotrexateDrug: Folic Acid

Placebo + Methotrexate

PLACEBO COMPARATOR
Drug: PlaceboDrug: MethotrexateDrug: Folic Acid

Interventions

SC12267 (4SC-101)DRUG

oral administration

SC12267 (4SC-101) + Methotrexate
PlaceboDRUG

oral administration

Placebo + Methotrexate
MethotrexateDRUG

oral administration

Placebo + MethotrexateSC12267 (4SC-101) + Methotrexate
Folic AcidDRUG

oral administration

Placebo + MethotrexateSC12267 (4SC-101) + Methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Leflunomide requires a 6 month washout period prior to Day 1 dosing
  • Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
  • Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing
  • Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
  • 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:
  • Sulfasalazine
  • Hydroxychloroquine
  • Use of corticosteroids \> 10 mg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

MHAT "Kaspela" Department of Rheumatology

Plovdiv, Bulgaria

Location

Diagnostic Consulting Centre "Sv. Anna"

Sofia, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic

Sofia, Bulgaria

Location

UMHAT "Sveti Ivan Rilski"

Sofia, Bulgaria

Location

Rheumatology Outpatient Clinic

Hlučín, Czechia

Location

Diagnostic Center Mediscan

Prague, Czechia

Location

Institute of Rheumatology

Prague, Czechia

Location

Centrum Miriada, Prywatny Gabinet Specjalistyczny

Bialystok, Poland

Location

Mazowieckie Centrum Badań Klinicznych s.c.

Grodzisk Mazowiecki, Poland

Location

Śląskie Centrum Osteoporozy

Katowice, Poland

Location

Specjalistyczny Ośrodek ALL-MED

Krakow, Poland

Location

NZOZ Reumed

Lublin, Poland

Location

Prof. Dr Hab. n. m. Leszek Szczepański

Lublin, Poland

Location

Poznański Ośrodek Medyczny NOVAMED

Poznan, Poland

Location

Wojewódzki Szpital Reumatologiczny

Sopot, Poland

Location

NZOZ "Nasz Lekarz"

Torun, Poland

Location

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

Warsaw, Poland

Location

Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów

Warsaw, Poland

Location

NZOZ Materia Medica

Wroclaw, Poland

Location

Clinic Hospital Sf. Maria

Bucharest, Romania

Location

Emergency Hospital "Prof. Dr. Gerota"

Bucharest, Romania

Location

SC Duomedical

Bucharest, Romania

Location

SC Ianuli Med Consult

Bucharest, Romania

Location

County Hospital Cluj - Rheumatology clinic

Cluj-Napoca, Romania

Location

Clinical County Hospital of Targoviste

Targoviste, Dambovita, Romania

Location

Private Practice Prof. Dr. Mioara Banciu

Timișoara, Romania

Location

Related Publications (2)

  • 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.

    PMID: 31621054DERIVED

  • 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.

    PMID: 20413687DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

vidofludimusMethotrexateFolic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stanisław Sierakowski, Prof. MD

    Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2009

First Posted

November 10, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

July 1, 2011

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

BU(5)CZ(3)PL(12)RO(7)