Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056
This study is ongoing, but not recruiting participants.
Sponsor:
UCB BIOSCIENCES, Inc.
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT01296711
First received: February 14, 2011
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the long term safety and tolerability of CDP6038 treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: CDP6038 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056 |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- The occurrence of any adverse event. [ Time Frame: From baseline through end of study (up to 5 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 12 ] [ Designated as safety issue: No ]
- Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
- Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
- American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
- American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- American College of Rheumatology 50 (ACR50) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
- American College of Rheumatology 70 (ACR70) response status [ Time Frame: From baseline of the prior study (RA0056) to Weeks 24, 48, and 96 ] [ Designated as safety issue: No ]
- DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ] [ Designated as safety issue: No ]
- DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
- DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
- DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ] [ Designated as safety issue: No ]
- DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ] [ Designated as safety issue: No ]
- DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
- Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
- Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ] [ Designated as safety issue: No ]
- Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ] [ Designated as safety issue: No ]
| Enrollment: | 190 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CDP6038 |
Biological: CDP6038
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject completed the RA0056 study (Week 12 Visit)
- 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 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
Exclusion Criteria:
- Subject has an ongoing serious adverse event from the RA0056 study
- Female subject of childbearing potential has a positive pregnancy test 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296711
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| United States, Arizona | |
| 166 | |
| Mesa, Arizona, United States | |
| 154 | |
| Phoenix, Arizona, United States | |
| 118 | |
| Scottsdale, Arizona, United States | |
| United States, Arkansas | |
| 103 | |
| Hot Springs, Arkansas, United States | |
| United States, California | |
| 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 | |
| United States, Connecticut | |
| 141 | |
| Hamden, Connecticut, United States | |
| United States, Delaware | |
| 111 | |
| Lewes, Delaware, United States | |
| United States, Florida | |
| 151 | |
| Debary, Florida, United States | |
| 114 | |
| Jupiter, Florida, United States | |
| 157 | |
| Tampa, Florida, United States | |
| 183 | |
| Tampa, Florida, United States | |
| United States, Idaho | |
| 116 | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| 160 | |
| Moline, Illinois, United States | |
| 168 | |
| Springfield, Illinois, United States | |
| United States, Iowa | |
| 133 | |
| Cedar Rapids, Iowa, United States | |
| United States, Kansas | |
| 172 | |
| Kansas City, Kansas, United States | |
| United States, Michigan | |
| 185 | |
| St. Clair Shores, Michigan, United States | |
| United States, Missouri | |
| 134 | |
| St Louis, Missouri, United States | |
| 112 | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| 102 | |
| Lincoln, Nebraska, United States | |
| United States, New Jersey | |
| 171 | |
| Freehold, New Jersey, United States | |
| 152 | |
| Toms River, New Jersey, United States | |
| United States, New York | |
| 174 | |
| Brooklyn, New York, United States | |
| United States, North Carolina | |
| 170 | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| 150 | |
| Cincinnati, Ohio, United States | |
| 100 | |
| Dayton, Ohio, United States | |
| United States, Oklahoma | |
| 110 | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| 165 | |
| Duncansville, Pennsylvania, United States | |
| United States, Tennessee | |
| 105 | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| 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 | |
| United States, Virginia | |
| 139 | |
| Chesapeake, Virginia, United States | |
| United States, Washington | |
| 175 | |
| Tacoma, Washington, United States | |
| United States, West Virginia | |
| 136 | |
| Beckley, West Virginia, United States | |
| 167 | |
| Clarksburg, West Virginia, United States | |
| Belgium | |
| 401 | |
| Brussels, Belgium | |
| 400 | |
| Liege, Belgium | |
| United Kingdom | |
| 206 | |
| Essex, United Kingdom | |
| 208 | |
| Southampton, United Kingdom | |
| 209 | |
| Torquay, United Kingdom | |
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. ( UCB BIOSCIENCES, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01296711 History of Changes |
| Other Study ID Numbers: | RA0057 |
| Study First Received: | February 14, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by UCB, Inc.:
|
Rheumatoid arthritis CDP6038 Interleukin-6 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013