Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: CDP6038Biological: Tocilizumab (Actemra or RoActemra)Other: Placebo scOther: Placebo iv
- Registration Number
- NCT01242488
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description CDP6038 60 mg sc every 2 weeks plus methotrexate CDP6038 - Placebo sc every 2 weeks plus methotrexate Placebo iv - CDP6038 60 mg sc every 4 weeks plus methotrexate Placebo iv - CDP6038 120 mg sc every 4 weeks plus methotrexate Placebo iv - Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate Tocilizumab (Actemra or RoActemra) - Placebo sc every 2 weeks plus methotrexate Placebo sc - Placebo sc every 4 weeks plus methotrexate Placebo sc - CDP6038 120 mg sc every 2 weeks plus methotrexate CDP6038 - CDP6038 120 mg sc every 2 weeks plus methotrexate Placebo iv - CDP6038 240 mg sc every 2 weeks plus methotrexate Placebo iv - Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate Placebo sc - Placebo sc every 4 weeks plus methotrexate Placebo iv - CDP6038 240 mg sc every 2 weeks plus methotrexate CDP6038 - CDP6038 240 mg sc every 4 weeks plus methotrexate Placebo iv - CDP6038 60 mg sc every 2 weeks plus methotrexate Placebo iv - CDP6038 60 mg sc every 4 weeks plus methotrexate CDP6038 - CDP6038 240 mg sc every 4 weeks plus methotrexate Placebo sc - CDP6038 60 mg sc every 4 weeks plus methotrexate Placebo sc - CDP6038 120 mg sc every 4 weeks plus methotrexate CDP6038 - CDP6038 120 mg sc every 4 weeks plus methotrexate Placebo sc - CDP6038 240 mg sc every 4 weeks plus methotrexate CDP6038 -
- Primary Outcome Measures
Name Time Method Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo Baseline, Week 12
- Secondary Outcome Measures
Name Time Method American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms. From Baseline to Week 12 American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms. From Baseline to Week 12 American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms. From Baseline to Week 12
Trial Locations
- Locations (82)
132
🇺🇸Houston, Texas, United States
181
🇺🇸Houston, Texas, United States
158
🇺🇸San Diego, California, United States
121
🇺🇸Salt Lake City, Utah, United States
118
🇺🇸Scottsdale, Arizona, United States
209
🇬🇧Torquay, Devon, United Kingdom
152
🇺🇸Toms River, New Jersey, United States
103
🇺🇸Hot Springs, Arkansas, United States
400
🇧🇪Liege, Belgium
166
🇺🇸Mesa, Arizona, United States
201
🇬🇧Wigan, Lancashire, United Kingdom
127
🇺🇸Covina, California, United States
154
🇺🇸Paradise Valley, Arizona, United States
125
🇺🇸Jonesboro, Arkansas, United States
177
🇺🇸Los Angeles, California, United States
184
🇺🇸Long Beach, California, United States
149
🇺🇸Sacramento, California, United States
104
🇺🇸Palo Alto, California, United States
164
🇺🇸Upland, California, United States
129
🇺🇸Santa Maria, California, United States
101
🇺🇸Trumbull, Connecticut, United States
137
🇺🇸Norwalk, Connecticut, United States
141
🇺🇸Hamden, Connecticut, United States
111
🇺🇸Lewes, Delaware, United States
176
🇺🇸Aventura, Florida, United States
151
🇺🇸DeBary, Florida, United States
178
🇺🇸Sarasota, Florida, United States
186
🇺🇸Daytona Beach, Florida, United States
114
🇺🇸Jupiter, Florida, United States
113
🇺🇸Stockbridge, Georgia, United States
156
🇺🇸Rock Island, Illinois, United States
183
🇺🇸Pinellas Park, Florida, United States
116
🇺🇸Idaho Falls, Idaho, United States
153
🇺🇸Savannah, Georgia, United States
157
🇺🇸Tampa, Florida, United States
168
🇺🇸Springfield, Illinois, United States
102
🇺🇸Lincoln, Nebraska, United States
133
🇺🇸Cedar Rapids, Iowa, United States
172
🇺🇸Kansas City, Kansas, United States
112
🇺🇸Saint Louis, Missouri, United States
171
🇺🇸Freehold, New Jersey, United States
134
🇺🇸Saint Louis, Missouri, United States
185
🇺🇸Saint Clair Shores, Michigan, United States
110
🇺🇸Oklahoma City, Oklahoma, United States
174
🇺🇸Brooklyn, New York, United States
163
🇺🇸New Brunswick, New Jersey, United States
100
🇺🇸Dayton, Ohio, United States
108
🇺🇸Columbus, Ohio, United States
150
🇺🇸Cincinnati, Ohio, United States
106
🇺🇸Nashville, Tennessee, United States
117
🇺🇸Wexford, Pennsylvania, United States
165
🇺🇸Duncansville, Pennsylvania, United States
105
🇺🇸Nashville, Tennessee, United States
128
🇺🇸Dallas, Texas, United States
126
🇺🇸Houston, Texas, United States
120
🇺🇸Amarillo, Texas, United States
135
🇺🇸Austin, Texas, United States
138
🇺🇸Houston, Texas, United States
139
🇺🇸Chesapeake, Virginia, United States
144
🇺🇸Tomball, Texas, United States
142
🇺🇸Victoria, Texas, United States
119
🇺🇸Seattle, Washington, United States
175
🇺🇸Tacoma, Washington, United States
136
🇺🇸Beckley, West Virginia, United States
401
🇧🇪Brussels, Belgium
206
🇬🇧Essex, United Kingdom
205
🇬🇧London, United Kingdom
204
🇬🇧Newcastle Upon Tyne, United Kingdom
208
🇬🇧Southampton, United Kingdom
140
🇺🇸South Miami, Florida, United States
130
🇺🇸Gainesville, Georgia, United States
143
🇺🇸Nassau Bay, Texas, United States
148
🇺🇸La Jolla, California, United States
107
🇺🇸Wildomar, California, United States
162
🇺🇸Newnan, Georgia, United States
145
🇺🇸Mesquite, Texas, United States
160
🇺🇸Moline, Illinois, United States
109
🇺🇸Belmont, North Carolina, United States
115
🇺🇸Rochester, New York, United States
170
🇺🇸Charlotte, North Carolina, United States
122
🇺🇸San Antonio, Texas, United States
167
🇺🇸Clarksburg, West Virginia, United States