Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients (RESPOND-EXT)
This study has been terminated.
(Analysis of data from 104RA202 failed to meet primary endpoint)
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00664573
First received: April 21, 2008
Last updated: March 4, 2010
Last verified: March 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 21, 2008 | ||||
| Last Updated Date | March 4, 2010 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To Observe The Long-Term treatment with BG9924 When Administered to Subjects with RA who Previously Participated in a Biogen Idec Study [ Time Frame: Duration of this study is 18 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00664573 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients | ||||
| Official Title ICMJE | Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202. | ||||
| Brief Summary | To observe the long-term treatment with BG9924 when administered to patients with RA who previously participated in a Biogen Idec Study. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Biological: Baminercept alfa (BG9924)
dosage administered as per Biogen-Idec protocol
Other Names:
|
||||
| Study Arm (s) |
|
||||
| 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 | Terminated | ||||
| Enrollment ICMJE | 339 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Argentina, Brazil, Hungary, Mexico, Poland, Romania, Russian Federation, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00664573 | ||||
| Other Study ID Numbers ICMJE | 104RA204 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Biogen Idec (Biogen Idec MD), Biogen Idec | ||||
| Study Sponsor ICMJE | Biogen Idec | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Biogen Idec | ||||
| Verification Date | March 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||