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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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Certolizumab Pegol (CZP) (Biological); Adalimumab (ADA) (Biological); Methotrexate (MTX) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: UCB Pharma SA

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Clinical Details

Official title: A Multicenter, Single-blind, Randomized Parallel-group 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 Responding Inadequately to Methotrexate

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percentage of subjects who meet the American College of Rheumatology 20 % (ACR20) criteria at Week 12

Percentage of subjects who have a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104

Secondary outcome:

Percentage of Week 12 responders who have a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104

Percentage of subjects who meet the American College of Rheumatology 20 % (ACR20) criteria at Week 6

Percentage of subjects who have a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6

Percentage of subjects who have a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12

Percentage of subjects with a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in subjects responding at both Week 6 and Week 12

Based on Week 12 responders, change from Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104

Time to all-cause study discontinuation, defined as the number of days from response at Week 12 until completion at Week 104 or withdrawal before Week 104

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined

by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)

- Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic

Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening

- Subject must have moderate to severe RA disease at Screening and Baseline defined as:

1. Screening (all criteria required)

- ≥ 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3. 2

- C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1. 0 mg/dL) or

Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr 2. Baseline (both criteria required)

- ≥ 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3. 2

- Subject must have inadequately responded previously to Methotrexate (MTX)

- Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has

used the same MTX regimen for a minimum of 28 days prior to Baseline Exclusion Criteria:

- Subject has previously received any biological Disease Modifying Antirheumatic Drug

(DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase

- Diagnosis of any other inflammatory arthritis

- Infected with Tuberculosis (TB) or high risk of acquiring TB infection

- Subjects with concurrent acute or chronic viral hepatitis B or C infection

- Subjects with a history of chronic or recurrent infections or subjects at high risk

of infection

- Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological

DMARDs excluding study medications, experimental therapy, IA hyaluronic acid

Locations and Contacts

22, Wien, Austria

18, Pleven, Bulgaria

35, Plovdiv, Bulgaria

21, Sofia, Bulgaria

29, Sofia, Bulgaria

34, Sofia, Bulgaria

46, Sofia, Bulgaria

221, Barrie, Canada

171, Quebec, Canada

103, Brno, Czech Republic

61, Hradec Kralove, Czech Republic

58, Plzen, Czech Republic

49, Praha, Czech Republic

40, Uherske Hradiste, Czech Republic

89, Brest, France

70, Le Mans, France

62, Lyon, France

72, Montpellier Cedex 5, France

90, Orleans, France

105, Toulouse Cedex 9, France

56, Berlin, Germany

47, Fulda, Germany

17, Hamburg, Germany

31, Heidelberg, Germany

37, Herne, Germany

64, Köln, Germany

63, Osnabrück, Germany

11, Ratingen, Germany

66, Rheine, Germany

71, Traunstein, Germany

44, Zerbst, Germany

13, Budapest, Hungary

42, Budapest, Hungary

68, Gyula, Hungary

100, Kistarcsa, Hungary

43, Szeged, Hungary

33, Veszprem, Hungary

23, Dublin, Ireland

20, Limerick, Ireland

80, Bergamo, Italy

38, Genova, Italy

39, Verona, Italy

193, Guadalajara, Mexico

192, Monterrey, Mexico

191, San Luis Potosi, Mexico

60, Monaco, Monaco

107, Bydgoszcz, Poland

106, Poznan, Poland

113, Warszawa, Poland

115, Warszawa, Poland

108, Wroclaw, Poland

76, Lisboa, Portugal

27, Lisbon, Portugal

14, Ponte De Lima, Portugal

81, Porto, Portugal

54, Bacau, Romania

74, Braila, Romania

24, Bucharest, Romania

25, Bucharest, Romania

28, Bucharest, Romania

32, Bucharest, Romania

57, Bucharest, Romania

12, Cluj-Napoca, Romania

96, Galati, Romania

26, Iasi, Romania

16, A Coruna, Spain

52, A Coruna, Spain

30, Madrid, Spain

82, Sabadell, Spain

65, Vigo, Spain

53, St. Gallen, Switzerland

50, Zürich, Switzerland

78, Brighton, United Kingdom

59, Leeds, United Kingdom

19, London, United Kingdom

77, Poole, United Kingdom

55, Sheffield, United Kingdom

73, Upton, United Kingdom

99, Wigan, United Kingdom

141, Birmingham, Alabama, United States

214, Tuscaloosa, Alabama, United States

159, Tucson, Arizona, United States

152, Hot Springs, Arkansas, United States

147, Covina, California, United States

161, Fullerton, California, United States

217, La Mesa, California, United States

144, Menifee, California, United States

185, Roseville, California, United States

208, Sacramento, California, United States

189, Van Nuys, California, United States

148, Whittier, California, United States

220, Lewes, Delaware, United States

142, Aventura, Florida, United States

216, Fort Lauderdale, Florida, United States

209, Vero Beach, Florida, United States

145, Coeur D'alene, Idaho, United States

134, Lexington, Kentucky, United States

178, Baltimore, Maryland, United States

137, Battle Creek, Michigan, United States

153, Detroit, Michigan, United States

155, Lansing, Michigan, United States

204, Eagan, Minnesota, United States

135, Omaha, Nebraska, United States

170, Reno, Nevada, United States

201, Teaneck, New Jersey, United States

150, Voorhees, New Jersey, United States

205, Albuquerque, New Mexico, United States

6, Camperdown, New South Wales, Australia

5, Kogarah, New South Wales, Australia

154, Albany, New York, United States

136, Brooklyn, New York, United States

219, Orchard Park, New York, United States

207, Plainview, New York, United States

167, Syracuse, New York, United States

168, St. John's, Newfoundland and Labrador, Canada

176, St. John's, Newfoundland and Labrador, Canada

183, Halifax, Nova Scotia, Canada

140, Cincinnati, Ohio, United States

184, Oklahoma City, Oklahoma, United States

172, Hamilton, Ontario, Canada

174, Hamilton, Ontario, Canada

206, Ottawa, Ontario, Canada

175, St. Catharines, Ontario, Canada

164, Bethlehem, Pennsylvania, United States

132, Duncansville, Pennsylvania, United States

190, Wyomissing, Pennsylvania, United States

218, Rimouski, Quebec, Canada

169, Sainte Foy, Quebec, Canada

2, Maroochydore, Queensland, Australia

210, Charleston, South Carolina, United States

187, Myrtle Beach, South Carolina, United States

203, Orangeburg, South Carolina, United States

4, Hobart, Tasmania, Australia

133, Jackson, Tennessee, United States

160, Knoxville, Tennessee, United States

138, Austin, Texas, United States

151, Corpus Christi, Texas, United States

131, Dallas, Texas, United States

146, Dallas, Texas, United States

166, Houston, Texas, United States

212, Houston, Texas, United States

139, San Antonio, Texas, United States

181, Sugar Land, Texas, United States

165, Victoria, Texas, United States

8, Fitzroy, Victoria, Australia

1, Malvern, Victoria, Australia

211, Arlington, Virginia, United States

157, Spokane, Washington, United States

163, Clarksburg, West Virginia, United States

3, Subiaco, Western Australia, Australia

215, Glendale, Wisconsin, United States

Additional Information

Starting date: December 2011
Last updated: July 14, 2015

Page last updated: August 23, 2015

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