Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01752855
First received: December 17, 2012
Last updated: March 15, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 17, 2012 | ||||||||
| Last Updated Date | March 15, 2013 | ||||||||
| Start Date ICMJE | December 2012 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01752855 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 | Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab | ||||||||
| Official Title ICMJE | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab | ||||||||
| Brief Summary | Phase 2b,open label, multicenter study in rheumatoid arthritis for subjects who completed the previous M13-390 study. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Rheumatoid Arthritis | ||||||||
| Intervention ICMJE | Biological: adalimumab
concentration 40mg/0.4mL
Other Name: Humira |
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| Study Arm (s) | Experimental: adalimumab
concentration 40mg/0.4 mL
Intervention: Biological: adalimumab |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Puerto Rico, Slovakia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01752855 | ||||||||
| Other Study ID Numbers ICMJE | M13-692, 2012-003881-42 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | AbbVie ( AbbVie (prior sponsor, Abbott) ) | ||||||||
| Study Sponsor ICMJE | AbbVie (prior sponsor, Abbott) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AbbVie | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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