A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

September 30, 2015

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Certolizumab Pegol + Methotrexate (MTX)

"Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.~On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).~CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.~The MTX treatment is to remain between 15-25 mg/week."

BIOLOGICAL

Placebo + Methotrexate (MTX)

"1 syringe of Placebo every 2 Weeks and MTX.~The MTX treatment is to remain between 15-25 mg/week."

Trial Locations (178)

Unknown

209, Birmingham

170, Huntsville

180, Mobile

247, Glendale

165, Paradise Valley

234, Paradise Valley

243, Phoenix

251, Tucson

160, Covina

257, Hemet

159, Los Angeles

201, San Leandro

202, Upland

172, Whittier

190, Fort Lauderdale

196, Jupiter

238, Lake Mary

232, Miami

213, Naples

214, Ocala

237, Orange Park

255, Orlando

163, Palm Harbor

166, Plantation

192, Sarasota

200, Vero Beach

226, Coeur d'Alene

244, Springfield

224, South Bend

215, Cedar Rapids

191, Wichita

210, Wichita

177, Hagerstown

199, Kalamazoo

198, Eagan

203, Tupelo

179, St Louis

181, Lincoln

256, Reno

229, Lebanon

228, Clifton

207, Albuquerque

176, Brooklyn

242, Plainview

227, Rochester

236, Durham

245, Middleburg Heights

241, Oklahoma City

186, Portland

195, Bethlehem

167, Duncansville

168, Wyomissing

189, Charleston

205, Columbia

204, Hendersonville

217, Allen

185, Amarillo

161, Austin

178, Corpus Christi

162, Dallas

184, Houston

206, Houston

223, Houston

158, Mesquite

175, Nassau Bay

249, Plano

197, San Antonio

233, Kennewick

183, Clarksburg

174, Glendale

276, Buenos Aires

284, Rosario

279, San Juan

291, San Miguel de Tucumán

6, Coffs Harbour

2, Herson

1, Maroochydore

8, Woodville South

5, Fitzroy

4, Geelong

3, Malvern

7, Perth

50, Vienna

51, Brussels

126, Gilly

36, Kortrijk

65, Yvoir

240, Kelowna

235, Hamilton

188, Montreal

194, Trois-Rivières

303, Barranquilla

272, Bogotá

293, Bogotá

299, Bogotá

297, Bucaramanga

288, Chía

271, Medellín

298, Medellín

108, Brno

124, Bruntál

38, Hradec Králové

37, Prague

16, Le Kremlin-Bicêtre

85, Le Mans

88, Montpellier

34, Orléans

79, Strasbourg

52, Bad Doberan

17, Bayreuth

113, Berlin

120, Berlin

89, Erfurt

70, Frankfurt

71, Hamburg

81, Hildesheim

127, Lingen

61, München

53, Planegg

132, Ratingen

49, Rendsburg

69, Rheine

114, Würzburg

59, Zerbst

18, Budapest

21, Budapest

86, Eger

131, Szolnok

110, Szombathely

19, Veszprém

33, Cork

54, Dublin

32, Limerick

115, Ferrara

122, Milan

40, Reggio Emilia

72, Roma

41, Verona

281, Durango

286, Guadalajara

292, Mexico City

302, Mérida

280, Monterrey

294, San Luis Potosí City

78, Monaco

42, Leiden

128, Bydgoszcz

67, Elblag

99, Krakow

92, Poznan

74, Torun

100, Warsaw

44, Wroclaw

58, Brasov

111, Bucharest

22, Bucharest

25, Bucharest

26, Bucharest

24, Iași

57, LASI

93, A Coruña

47, Madrid

63, Santiago de Compostela

76, Gothenburg

82, Huddinge

106, Lund

123, Malmo

77, Stockholm

75, Uppsala

118, Fribourg

68, Sankt Gallen

125, Cannock

105, Dudley

56, Leeds

121, London

27, London

80, Sheffield

119, York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY