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Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

NCT ID: NCT01242488

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.

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A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

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Detailed Description

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CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week, randomized, double-blind, placebo- and active- controlled study comparing several doses and dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in patients with active rheumatoid arthritis who have had an unsuccessful response to methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12 weeks while maintaining an adequate safety profile. In order to maintain the study blinding all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on stable weekly doses of methotrexate. Assessments during the study include evaluations of joint pain and swelling, laboratory blood and urine tests, physical examinations, vital signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will be eligible to enroll in a long-term extension study receiving CDP6038.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CDP6038 60 mg sc every 2 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

CDP6038 60 mg sc every 4 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

60 mg sc at Weeks 0, 4 and 8

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 2, 6 and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

CDP6038 120 mg sc every 2 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

120 mg sc at Weeks 0, 2, 4 6, 8, and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

CDP6038 120 mg sc every 4 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

120 mg sc at Weeks 0, 4 and 8

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 2, 6 and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

CDP6038 240 mg sc every 2 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

240 mg sc at Weeks 0, 2, 4 6, 8, and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

CDP6038 240 mg sc every 4 weeks plus methotrexate

Group Type EXPERIMENTAL

CDP6038

Intervention Type BIOLOGICAL

240 mg sc at Weeks 0, 4 and 8

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 2, 6 and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate

Group Type ACTIVE_COMPARATOR

Tocilizumab (Actemra or RoActemra)

Intervention Type BIOLOGICAL

8 mg/kg intravenously (iv) at Weeks 0, 4 and 8

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10

Placebo sc every 2 weeks plus methotrexate

Group Type PLACEBO_COMPARATOR

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Placebo sc every 4 weeks plus methotrexate

Group Type PLACEBO_COMPARATOR

Placebo sc

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10

Placebo iv

Intervention Type OTHER

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Interventions

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CDP6038

60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10

Intervention Type BIOLOGICAL

CDP6038

120 mg sc at Weeks 0, 2, 4 6, 8, and 10

Intervention Type BIOLOGICAL

CDP6038

240 mg sc at Weeks 0, 2, 4 6, 8, and 10

Intervention Type BIOLOGICAL

Tocilizumab (Actemra or RoActemra)

8 mg/kg intravenously (iv) at Weeks 0, 4 and 8

Intervention Type BIOLOGICAL

CDP6038

60 mg sc at Weeks 0, 4 and 8

Intervention Type BIOLOGICAL

CDP6038

240 mg sc at Weeks 0, 4 and 8

Intervention Type BIOLOGICAL

CDP6038

120 mg sc at Weeks 0, 4 and 8

Intervention Type BIOLOGICAL

Placebo sc

0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10

Intervention Type OTHER

Placebo sc

0.9% Sodium chloride for injection at Weeks 2, 6 and 10

Intervention Type OTHER

Placebo iv

0.9% Sodium chloride for injection at Weeks 0, 4 and 8

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
* Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to \< 12.5mg/week are allowed if there is documented intolerance
* Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
* CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
* Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening

Exclusion Criteria

* Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
* Wheelchair bound or bedridden.
* Disease modifying antirheumatic drugs (DMARDs) other than MTX.
* Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
* Treatment with other biologics within 4-24 weeks (depending on the biologic)
* History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
* Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
* Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
* Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
* History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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166

Mesa, Arizona, United States

Site Status

154

Paradise Valley, Arizona, United States

Site Status

118

Scottsdale, Arizona, United States

Site Status

103

Hot Springs, Arkansas, United States

Site Status

125

Jonesboro, Arkansas, United States

Site Status

127

Covina, California, United States

Site Status

148

La Jolla, California, United States

Site Status

184

Long Beach, California, United States

Site Status

177

Los Angeles, California, United States

Site Status

104

Palo Alto, California, United States

Site Status

149

Sacramento, California, United States

Site Status

158

San Diego, California, United States

Site Status

129

Santa Maria, California, United States

Site Status

164

Upland, California, United States

Site Status

107

Wildomar, California, United States

Site Status

141

Hamden, Connecticut, United States

Site Status

137

Norwalk, Connecticut, United States

Site Status

101

Trumbull, Connecticut, United States

Site Status

111

Lewes, Delaware, United States

Site Status

176

Aventura, Florida, United States

Site Status

186

Daytona Beach, Florida, United States

Site Status

151

DeBary, Florida, United States

Site Status

114

Jupiter, Florida, United States

Site Status

183

Pinellas Park, Florida, United States

Site Status

178

Sarasota, Florida, United States

Site Status

140

South Miami, Florida, United States

Site Status

157

Tampa, Florida, United States

Site Status

130

Gainesville, Georgia, United States

Site Status

162

Newnan, Georgia, United States

Site Status

153

Savannah, Georgia, United States

Site Status

113

Stockbridge, Georgia, United States

Site Status

116

Idaho Falls, Idaho, United States

Site Status

160

Moline, Illinois, United States

Site Status

156

Rock Island, Illinois, United States

Site Status

168

Springfield, Illinois, United States

Site Status

133

Cedar Rapids, Iowa, United States

Site Status

172

Kansas City, Kansas, United States

Site Status

185

Saint Clair Shores, Michigan, United States

Site Status

112

St Louis, Missouri, United States

Site Status

134

St Louis, Missouri, United States

Site Status

102

Lincoln, Nebraska, United States

Site Status

171

Freehold, New Jersey, United States

Site Status

163

New Brunswick, New Jersey, United States

Site Status

152

Toms River, New Jersey, United States

Site Status

174

Brooklyn, New York, United States

Site Status

115

Rochester, New York, United States

Site Status

109

Belmont, North Carolina, United States

Site Status

170

Charlotte, North Carolina, United States

Site Status

150

Cincinnati, Ohio, United States

Site Status

108

Columbus, Ohio, United States

Site Status

100

Dayton, Ohio, United States

Site Status

110

Oklahoma City, Oklahoma, United States

Site Status

165

Duncansville, Pennsylvania, United States

Site Status

117

Wexford, Pennsylvania, United States

Site Status

105

Nashville, Tennessee, United States

Site Status

106

Nashville, Tennessee, United States

Site Status

120

Amarillo, Texas, United States

Site Status

135

Austin, Texas, United States

Site Status

128

Dallas, Texas, United States

Site Status

126

Houston, Texas, United States

Site Status

132

Houston, Texas, United States

Site Status

138

Houston, Texas, United States

Site Status

181

Houston, Texas, United States

Site Status

145

Mesquite, Texas, United States

Site Status

143

Nassau Bay, Texas, United States

Site Status

122

San Antonio, Texas, United States

Site Status

144

Tomball, Texas, United States

Site Status

142

Victoria, Texas, United States

Site Status

121

Salt Lake City, Utah, United States

Site Status

139

Chesapeake, Virginia, United States

Site Status

119

Seattle, Washington, United States

Site Status

175

Tacoma, Washington, United States

Site Status

136

Beckley, West Virginia, United States

Site Status

167

Clarksburg, West Virginia, United States

Site Status

401

Brussels, , Belgium

Site Status

400

Liège, , Belgium

Site Status

209

Torquay, Devon, United Kingdom

Site Status

201

Wigan, Lancashire, United Kingdom

Site Status

206

Essex, , United Kingdom

Site Status

205

London, , United Kingdom

Site Status

204

Newcastle upon Tyne, , United Kingdom

Site Status

208

Southampton, , United Kingdom

Site Status

Countries

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United States Belgium United Kingdom

References

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Genovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18.

Reference Type DERIVED
PMID: 24641941 (View on PubMed)

Other Identifiers

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2010-020839-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RA0056

Identifier Type: -

Identifier Source: org_study_id

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