Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
NCT ID: NCT01296711
Last Updated: 2022-04-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
190 participants
INTERVENTIONAL
2011-03-07
2013-08-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDP6038 (olokizumab)
CDP6038 (olokizumab)
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Interventions
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CDP6038 (olokizumab)
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of administration for at least 12 weeks
* Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
* Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
* Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)
Exclusion Criteria
* Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
* Subject has evidence of active or latent tuberculosis
* Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
* Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (\~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
* Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study
18 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Genovese, Dr
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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166
Mesa, Arizona, United States
154
Phoenix, Arizona, United States
118
Scottsdale, Arizona, United States
103
Hot Springs, 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
129
Santa Maria, California, United States
164
Upland, California, United States
141
Hamden, Connecticut, United States
111
Lewes, Delaware, United States
151
DeBary, Florida, United States
114
Jupiter, Florida, United States
157
Tampa, Florida, United States
183
Tampa, Florida, United States
116
Idaho Falls, Idaho, United States
160
Moline, 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
152
Toms River, New Jersey, United States
174
Brooklyn, New York, United States
170
Charlotte, North Carolina, United States
150
Cincinnati, Ohio, United States
100
Dayton, Ohio, United States
110
Oklahoma City, Oklahoma, United States
165
Duncansville, Pennsylvania, United States
105
Nashville, Tennessee, 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
139
Chesapeake, Virginia, 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
206
Essex, , United Kingdom
208
Southampton, , United Kingdom
209
Torquay, , United Kingdom
Countries
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Other Identifiers
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2010-022224-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RA0057
Identifier Type: -
Identifier Source: org_study_id
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