Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
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
2 other identifiers
interventional
221
3 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Nov 2010
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 17, 2024
July 1, 2024
1.6 years
November 15, 2010
July 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo
Baseline, Week 12
Secondary Outcomes (3)
American College of Rheumatology 20% response (ACR20) 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 70% response (ACR70) rates for the CDP6038 and placebo arms.
From Baseline to Week 12
Study Arms (9)
CDP6038 60 mg sc every 2 weeks plus methotrexate
EXPERIMENTALCDP6038 60 mg sc every 4 weeks plus methotrexate
EXPERIMENTALCDP6038 120 mg sc every 2 weeks plus methotrexate
EXPERIMENTALCDP6038 120 mg sc every 4 weeks plus methotrexate
EXPERIMENTALCDP6038 240 mg sc every 2 weeks plus methotrexate
EXPERIMENTALCDP6038 240 mg sc every 4 weeks plus methotrexate
EXPERIMENTALTocilizumab 8 mg/kg iv every 4 weeks plus methotrexate
ACTIVE COMPARATORPlacebo sc every 2 weeks plus methotrexate
PLACEBO COMPARATORPlacebo sc every 4 weeks plus methotrexate
PLACEBO COMPARATORInterventions
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
0.9% Sodium chloride for injection at Weeks 0, 4 and 8
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (82)
166
Mesa, Arizona, United States
154
Paradise Valley, Arizona, United States
118
Scottsdale, Arizona, United States
103
Hot Springs, Arkansas, United States
125
Jonesboro, Arkansas, United States
127
Covina, California, United States
148
La Jolla, California, United States
184
Long Beach, California, United States
177
Los Angeles, California, United States
104
Palo Alto, California, United States
149
Sacramento, California, United States
158
San Diego, California, United States
129
Santa Maria, California, United States
164
Upland, California, United States
107
Wildomar, California, United States
141
Hamden, Connecticut, United States
137
Norwalk, Connecticut, United States
101
Trumbull, Connecticut, United States
111
Lewes, Delaware, United States
176
Aventura, Florida, United States
186
Daytona Beach, Florida, United States
151
DeBary, Florida, United States
114
Jupiter, Florida, United States
183
Pinellas Park, Florida, United States
178
Sarasota, Florida, United States
140
South Miami, Florida, United States
157
Tampa, Florida, United States
130
Gainesville, Georgia, United States
162
Newnan, Georgia, United States
153
Savannah, Georgia, United States
113
Stockbridge, Georgia, United States
116
Idaho Falls, Idaho, United States
160
Moline, Illinois, United States
156
Rock Island, Illinois, United States
168
Springfield, Illinois, United States
133
Cedar Rapids, Iowa, United States
172
Kansas City, Kansas, United States
185
Saint Clair Shores, Michigan, United States
112
St Louis, Missouri, United States
134
St Louis, Missouri, United States
102
Lincoln, Nebraska, United States
171
Freehold, New Jersey, United States
163
New Brunswick, New Jersey, United States
152
Toms River, New Jersey, United States
174
Brooklyn, New York, United States
115
Rochester, New York, United States
109
Belmont, North Carolina, United States
170
Charlotte, North Carolina, United States
150
Cincinnati, Ohio, United States
108
Columbus, Ohio, United States
100
Dayton, Ohio, United States
110
Oklahoma City, Oklahoma, United States
165
Duncansville, Pennsylvania, United States
117
Wexford, Pennsylvania, United States
105
Nashville, Tennessee, United States
106
Nashville, Tennessee, United States
120
Amarillo, Texas, United States
135
Austin, Texas, United States
128
Dallas, Texas, United States
126
Houston, Texas, United States
132
Houston, Texas, United States
138
Houston, Texas, United States
181
Houston, Texas, United States
145
Mesquite, Texas, United States
143
Nassau Bay, Texas, United States
122
San Antonio, Texas, United States
144
Tomball, Texas, United States
142
Victoria, Texas, United States
121
Salt Lake City, Utah, United States
139
Chesapeake, Virginia, United States
119
Seattle, Washington, United States
175
Tacoma, Washington, United States
136
Beckley, West Virginia, United States
167
Clarksburg, West Virginia, United States
401
Brussels, Belgium
400
Liège, Belgium
209
Torquay, Devon, United Kingdom
201
Wigan, Lancashire, United Kingdom
206
Essex, United Kingdom
205
London, United Kingdom
204
Newcastle upon Tyne, United Kingdom
208
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 24641941DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 17, 2010
Study Start
November 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 17, 2024
Record last verified: 2024-07