Rheumatoid Arthritis Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
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.
Status | Completed |
Enrollment | 221 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | 401 | Brussels | |
Belgium | 400 | Liege | |
United Kingdom | 206 | Essex | |
United Kingdom | 205 | London | |
United Kingdom | 204 | Newcastle Upon Tyne | |
United Kingdom | 208 | Southampton | |
United Kingdom | 209 | Torquay | Devon |
United Kingdom | 201 | Wigan | Lancashire |
United States | 120 | Amarillo | Texas |
United States | 135 | Austin | Texas |
United States | 176 | Aventura | Florida |
United States | 136 | Beckley | West Virginia |
United States | 109 | Belmont | North Carolina |
United States | 174 | Brooklyn | New York |
United States | 133 | Cedar Rapids | Iowa |
United States | 170 | Charlotte | North Carolina |
United States | 139 | Chesapeake | Virginia |
United States | 150 | Cincinnati | Ohio |
United States | 167 | Clarksburg | West Virginia |
United States | 108 | Columbus | Ohio |
United States | 127 | Covina | California |
United States | 128 | Dallas | Texas |
United States | 100 | Dayton | Ohio |
United States | 186 | Daytona | Florida |
United States | 151 | Debary | Florida |
United States | 165 | Duncansville | Pennsylvania |
United States | 171 | Freehold | New Jersey |
United States | 130 | Gainesville | Georgia |
United States | 141 | Hamden | Connecticut |
United States | 103 | Hot Springs | Arkansas |
United States | 126 | Houston | Texas |
United States | 132 | Houston | Texas |
United States | 138 | Houston | Texas |
United States | 181 | Houston | Texas |
United States | 116 | Idaho Falls | Idaho |
United States | 125 | Jonesboro | Arkansas |
United States | 114 | Jupiter | Florida |
United States | 172 | Kansas City | Kansas |
United States | 148 | La Jolla | California |
United States | 111 | Lewes | Delaware |
United States | 102 | Lincoln | Nebraska |
United States | 184 | Long Beach | California |
United States | 177 | Los Angeles | California |
United States | 166 | Mesa | Arizona |
United States | 145 | Mesquite | Texas |
United States | 160 | Moline | Illinois |
United States | 105 | Nashville | Tennessee |
United States | 106 | Nashville | Tennessee |
United States | 143 | Nassau Bay | Texas |
United States | 163 | New Brunswick | New Jersey |
United States | 162 | Newnan | Georgia |
United States | 137 | Norwalk | Connecticut |
United States | 110 | Oklahoma City | Oklahoma |
United States | 104 | Palo Alto | California |
United States | 154 | Paradise Valley | Arizona |
United States | 183 | Pinellas Park | Florida |
United States | 115 | Rochester | New York |
United States | 156 | Rock Island | Illinois |
United States | 149 | Sacramento | California |
United States | 121 | Salt Lake City | Utah |
United States | 122 | San Antonio | Texas |
United States | 158 | San Diego | California |
United States | 129 | Santa Maria | California |
United States | 178 | Sarasota | Florida |
United States | 153 | Savannah | Georgia |
United States | 118 | Scottsdale | Arizona |
United States | 119 | Seattle | Washington |
United States | 140 | South Miami | Florida |
United States | 168 | Springfield | Illinois |
United States | 185 | St. Clair Shores | Michigan |
United States | 112 | St. Louis | Missouri |
United States | 134 | St. Louis | Missouri |
United States | 113 | Stockbridge | Georgia |
United States | 175 | Tacoma | Washington |
United States | 157 | Tampa | Florida |
United States | 144 | Tomball | Texas |
United States | 152 | Toms River | New Jersey |
United States | 101 | Trumbull | Connecticut |
United States | 164 | Upland | California |
United States | 142 | Victoria | Texas |
United States | 117 | Wexford | Pennsylvania |
United States | 107 | Wildomar | California |
Lead Sponsor | Collaborator |
---|---|
UCB Pharma |
United States, Belgium, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo | Baseline, Week 12 | No | |
Secondary | American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms. | From Baseline to Week 12 | No | |
Secondary | American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms. | From Baseline to Week 12 | No | |
Secondary | American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms. | From Baseline to Week 12 | No |
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