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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Baseline, Week 12
No
UCB Clinical Trial Call Center
Study Director
+1 877 822 9493 (UCB)
Belgium: Federal Agency for Medicinal Products and Health Products
RA0056
NCT01242488
November 2010
June 2012
Name | Location |
---|---|
166 | Mesa, Arizona |
154 | Paradise Valley, Arizona |
118 | Scottsdale, Arizona |
103 | Hot Springs, Arkansas |
125 | Jonesboro, Arkansas |
127 | Covina, California |
148 | La Jolla, California |
184 | Long Beach, California |
177 | Los Angeles, California |
104 | Palo Alto, California |
149 | Sacramento, California |
158 | San Diego, California |
129 | Santa Maria, California |
164 | Upland, California |
107 | Wildomar, California |
141 | Hamden, Connecticut |
137 | Norwalk, Connecticut |
101 | Trumbull, Connecticut |
111 | Lewes, Delaware |
176 | Aventura, Florida |
186 | Daytona, Florida |
151 | Debary, Florida |
114 | Jupiter, Florida |
183 | Pinellas Park, Florida |
178 | Sarasota, Florida |
140 | South Miami, Florida |
157 | Tampa, Florida |
130 | Gainesville, Georgia |
162 | Newnan, Georgia |
153 | Savannah, Georgia |
113 | Stockbridge, Georgia |
116 | Idaho Falls, Idaho |
160 | Moline, Illinois |
156 | Rock Island, Illinois |
168 | Springfield, Illinois |
133 | Cedar Rapids, Iowa |
172 | Kansas City, Kansas |
185 | St. Clair Shores, Michigan |
112 | St. Louis, Missouri |
134 | St. Louis, Missouri |
102 | Lincoln, Nebraska |
171 | Freehold, New Jersey |
163 | New Brunswick, New Jersey |
152 | Toms River, New Jersey |
174 | Brooklyn, New York |
115 | Rochester, New York |
109 | Belmont, North Carolina |
170 | Charlotte, North Carolina |
150 | Cincinnati, Ohio |
108 | Columbus, Ohio |
100 | Dayton, Ohio |
110 | Oklahoma City, Oklahoma |
165 | Duncansville, Pennsylvania |
117 | Wexford, Pennsylvania |
105 | Nashville, Tennessee |
106 | Nashville, Tennessee |
120 | Amarillo, Texas |
135 | Austin, Texas |
128 | Dallas, Texas |
126 | Houston, Texas |
132 | Houston, Texas |
138 | Houston, Texas |
181 | Houston, Texas |
145 | Mesquite, Texas |
143 | Nassau Bay, Texas |
122 | San Antonio, Texas |
144 | Tomball, Texas |
142 | Victoria, Texas |
121 | Salt Lake City, Utah |
139 | Chesapeake, Virginia |
119 | Seattle, Washington |
175 | Tacoma, Washington |
136 | Beckley, West Virginia |
167 | Clarksburg, West Virginia |