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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 14, 2011 | ||||
| Last Updated Date | March 28, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The occurrence of any adverse event. [ Time Frame: From baseline through end of study (up to 5 years) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01296711 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056 | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Biological: CDP6038
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks |
||||
| Study Arm (s) | Experimental: CDP6038
Intervention: Biological: CDP6038 |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 190 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Belgium, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01296711 | ||||
| Other Study ID Numbers ICMJE | RA0057 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | UCB, Inc. ( UCB BIOSCIENCES, Inc. ) | ||||
| Study Sponsor ICMJE | UCB BIOSCIENCES, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | UCB, Inc. | ||||
| Verification Date | March 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||