Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

PHASE4CompletedINTERVENTIONAL
Enrollment

915

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

November 30, 2015

Study Completion Date

January 31, 2016

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

Certolizumab Pegol (CZP)

"* Active substance: an injectable volume of 1 ml solution for injection CZP~* Pharmaceutical form: prefilled syringes CZP~* Concentration: 200 mg/ml CZP~* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal."

BIOLOGICAL

Adalimumab (ADA)

"* Active substance: an injectable volume of 0.8 ml solution for injection ADA~* Pharmaceutical form: prefilled syringes ADA~* Concentration: 40 mg/0.8 ml ADA~* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal."

DRUG

Methotrexate (MTX)

"* Active substance: Methotrexate~* Pharmaceutical form: oral tablet~* Concentration: 15-25 mg/week~* Route of Administration: MTX orally"

Trial Locations (175)

Unknown

141, Birmingham

214, Tuscaloosa

159, Tucson

152, Hot Springs

147, Covina

161, Fullerton

217, La Mesa

149, Los Angeles

144, Menifee

185, Roseville

208, Sacramento

189, Van Nuys

148, Whittier

220, Lewes

142, Aventura

216, Fort Lauderdale

162, Gainesville

209, Vero Beach

145, Coeur d'Alene

202, Maywood

134, Lexington

178, Baltimore

137, Battle Creek

153, Detroit

155, Lansing

204, Eagan

180, Rochester

143, Saint Louis Park

135, Omaha

170, Reno

201, Teaneck

150, Voorhees Township

205, Albuquerque

154, Albany

136, Brooklyn

219, Orchard Park

207, Plainview

167, Syracuse

140, Cincinnati

184, Oklahoma City

164, Bethlehem

132, Duncansville

190, Wyomissing

210, Charleston

187, Myrtle Beach

203, Orangeburg

133, Jackson

160, Knoxville

138, Austin

151, Corpus Christi

131, Dallas

146, Dallas

213, Dallas

166, Houston

212, Houston

139, San Antonio

181, Sugar Land

165, Victoria

211, Arlington

157, Spokane

163, Clarksburg

215, Glendale

6, Camperdown

5, Kogarah

2, Maroochydore

4, Hobart

7, Clayton

8, Fitzroy

1, Malvern

3, Subiaco

85, Stockerau

22, Vienna

18, Pleven

35, Plovdiv

21, Sofia

29, Sofia

34, Sofia

46, Sofia

179, Edmonton

168, St. John's

176, St. John's

183, Halifax

172, Hamilton

174, Hamilton

177, Ottawa

206, Ottawa

175, St. Catharines

218, Rimouski

169, Sainte-Foy

221, Barrie

171, Québec

103, Brno

61, Hradec Králové

58, Pilsen

49, Prague

40, Uherské Hradiště

89, Brest

70, Le Mans

62, Lyon

72, Montpellier

90, Orléans

105, Toulouse

56, Berlin

64, Cologne

47, Fulda

17, Hamburg

31, Heidelberg

37, Herne

63, Osnabrück

11, Ratingen

66, Rheine

48, Rostock

71, Traunstein

44, Zerbst

94, Heraklion

95, Larissa

13, Budapest

42, Budapest

68, Gyula

100, Kistarcsa

43, Szeged

33, Veszprém

23, Dublin

51, Dublin

20, Limerick

80, Bergamo

38, Genova

88, Genova

79, Magenta

98, Napoli

67, Prato

36, Roma

39, Verona

194, Chihuahua City

195, Chihuahua City

193, Guadalajara

192, Monterrey

191, San Luis Potosí City

60, Monaco

107, Bydgoszcz

106, Poznan

113, Warsaw

115, Warsaw

108, Wroclaw

69, Coimbra

27, Lisbon

76, Lisbon

14, Ponte de Lima

81, Porto

54, Bacau

74, Brăila

24, Bucharest

25, Bucharest

28, Bucharest

32, Bucharest

57, Bucharest

12, Cluj-Napoca

96, Galati

26, Iași

16, A Coruña

52, A Coruña

30, Madrid

83, Madrid

82, Sabadell

65, Vigo

53, Sankt Gallen

50, Zurich

86, Ashford

78, Brighton

59, Leeds

19, London

77, Poole

55, Sheffield

73, Upton

99, Wigan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

UCB Pharma SA

INDUSTRY