Clinical trial NCT01010581: SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
SC12267
4SC-101
Methotrexate
Phase II
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy of SC12267 (4SC-101) in combination with methotrexate in patients with RA
timeFrame: 13 weeks
Secondary outcomes:
measure: Evaluation of the safety of the combination of SC12267 (4SC-101) and methotrexate in patients with RA
timeFrame: 13 weeks
measure: Evaluation of the plasma concentration (trough value) of SC12267 (4SC-101) after once daily application in combination with methotrexate after once weekly administration.
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT "Kaspela" Department of Rheumatology
city: Sofia
country: Bulgaria
facility: Diagnostic Consulting Centre "Sv. Anna"
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: National Multiprofile Transport Hospital "Tsar Boris III" Internal Clinic
city: Sofia
country: Bulgaria
facility: UMHAT "Sveti Ivan Rilski"
city: Hlučín
country: Czech Republic
facility: Rheumatology Outpatient Clinic
city: Praha 11
country: Czech Republic
facility: Diagnostic Center Mediscan
city: Praha
country: Czech Republic
facility: Institute of Rheumatology
city: Białystok
country: Poland
facility: Centrum Miriada, Prywatny Gabinet Specjalistyczny
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badań Klinicznych s.c.
city: Katowice
country: Poland
facility: Śląskie Centrum Osteoporozy
city: Kraków
country: Poland
facility: Specjalistyczny Ośrodek ALL-MED
city: Lublin
country: Poland
facility: NZOZ Reumed
city: Lublin
country: Poland
facility: Prof. Dr Hab. n. m. Leszek Szczepański
city: Poznań
country: Poland
facility: Poznański Ośrodek Medyczny NOVAMED
city: Sopot
country: Poland
facility: Wojewódzki Szpital Reumatologiczny
city: Toruń
country: Poland
facility: NZOZ "Nasz Lekarz"
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
city: Warszawa
country: Poland
facility: Centrum Medyczne Osteomed NZOZ Lecznica Specjalistów
city: Wrocław
country: Poland
facility: NZOZ Materia Medica
city: Bucharest
country: Romania
facility: Clinic Hospital Sf. Maria
city: Bucharest
country: Romania
facility: Emergency Hospital "Prof. Dr. Gerota"
city: Bucharest
country: Romania
facility: SC Duomedical
city: Bucharest
country: Romania
facility: SC Ianuli Med Consult
city: Cluj Napoca
country: Romania
facility: County Hospital Cluj - Rheumatology clinic
city: Targoviste, Dambovita
country: Romania
facility: Clinical County Hospital of Targoviste
city: Timisoara
country: Romania
facility: Private Practice Prof. Dr. Mioara Banciu
Study officials:
affiliation: Centrum Miriada, Prywatny Gabinet Specjalistyczny, Bialystok, Poland
name: Stanisław Sierakowski, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.