Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
Tracking Information | |
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First Received Date ICMJE | March 18, 2005 |
Last Updated Date | July 10, 2008 |
Start Date ICMJE | February 2005 |
Primary Completion Date | |
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 NCT00105976 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX) |
Official Title ICMJE | A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate |
Brief Summary | The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both the mother and the fetus are much higher than normal. It has been observed that women with RA (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third trimester. At this time, the levels of AFP in the blood of the mother and fetus are the highest. This observation led researchers to begin examining AFP as a possible treatment for RA. |
Detailed Description | |
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 Primary Purpose: Treatment |
Condition ICMJE | Rheumatoid Arthritis |
Intervention ICMJE | Drug: MM-093 |
Study Arm (s) | |
Publications * | |
* 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 | Completed |
Enrollment ICMJE | 260 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 80 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00105976 |
Other Study ID Numbers ICMJE | MM-093-01-200 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Merrimack Pharmaceuticals |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Merrimack Pharmaceuticals |
Verification Date | July 2008 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |