GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Rheumatoid Arthritis
Interventions
DRUG

GLPG0259 oral capsule

Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)

DRUG

Placebo

Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule

DRUG

GLPG0259 (Part B)

Capsule, dosage to be established based on results of Part A

DRUG

Placebo (Part B)

Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)

Trial Locations (32)

1200

Cliniques Universitaires Saint-Luc, Brussels

3000

KU Leuven, Leuven

8340

AZ Alma, Sijsele-Damme

21018

Vinnytsia Regional Hospital, Vinnytsia

58000

Chernivtsi Regional Clinical Hospital, Chernivtsi

61002

Kharkiv City Clinical Hospital No.27, Kharkiv

61176

Kharkiv City Clinical Hospital No.8, Kharkiv

69600

Zaporizhzhia Regional Hospital, Zaporizhzhya

83000

Donetsk City Hospital No5, Donetsk

95006

University Clinic, Crimean Medical University, Simferopol

109240

"State Educational Institution of Higher Professional Education Moscow State Medico-Stomatological University of Roszdrav State Healthcare Institution of City Moscow City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. Medsantrud", Moscow

"State Healthcare Institution of city Moscow City Clinical Ordena Trudovogo Krasnogo Znameny Hospital #23 n.a. Medsantrud", Moscow

111539

"State Educational Institution of Higher Professional Education Russian State Medical University of Roszdrav State Healthcare Institution of City Moscow City Clinical Hospital #15 n.a. O.M. Filatov", Moscow

115093

"State Healthcare Institution of City Moscow City Clinical Hospital #4", Moscow

115446

"State Healthcare Institution of City Moscow City Clinical Hospital #7", Moscow

115522

Institution Russian Academy of Medical Sciences Scientific Research Institution of Rheumatology RAMN, Moscow

119049

"State Healthcare Institution of City Moscow City Clinical Hospital #1 n.a. Pirogov", Moscow

119106

"Saint-Petersburg State Healthcare Institution City Pokrovskaya Hospital", Saint Petersburg

121374

"State Educational Institution of Higher Professional Education Moscow State Medico-Stomatological University of Roszdrav at the State Healthcare Institution of city Moscow City Clinical Ordena Trudovogo Krasnogo Znameny hospital #23 n.a. M", Moscow

191104

"Saint-Petersburg State Healthcare Institution City Mariinskiy Hospital", Saint Petersburg

194017

Institution of Russian Academy of Sciences Saint-Petersburg Clinical Hospital RAN, Saint Petersburg

194100

"State Educational Institution of Higher Professional Education Saint-Petersburg State Pediatric Medical Academy of Roszdrav", Saint Petersburg

196247

"Saint-Petersburg State Healthcare Institution City Hospital #26", Moscow

2300RC

UMC Leiden, Leiden

30-349

Specjalistyczne Centrum Medyczne NZOZ NOWOMED, Krakow

00-235

"Linea Corporis - Chirurgia Plastyczna Sp. z o.o.", Warsaw

02-620

Mokotowskie Centrum Osteoporozy S.C., Warsaw

50-088

Synexus SCM Sp. z o.o., Wroclaw

50-556

Akademia Medyczna im. Piastów Śląskich we Wroclawiu Katedra i Klinika Reumatologii i Chorób Wewnętrznych UM we Wrocławiu, Wroclaw

02125

Kyiv City Clinical Hospital No.3, Kyiv

04053

Central Pool-type Clinical Hospital MoH of Ukraine, Kyiv

04114

Institute of Gerontology AMS of Ukraine, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Galapagos NV

INDUSTRY