Rheumatoid Arthritis Clinical Trial
Official title:
A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis
This study will treat moderate to severe rheumatoid arthritis with MRC375 (either 75 mg 3 times a day, 150 mg 3 times a day or placebo 3 times a day)in patients 18 years of age or older that can be currently on low doses of methotrexate or can stop treatment of current RA medications to enter the study. Safety of MRC375 will also be evaluated. There are up to 8 clinic visits over 24 weeks.
This is a double-blind, randomized, placebo-controlled study to assess the safety and
efficacy of MRC375 at 75 mg or 150 mg with matching placebo (taken tid with meal or light
snack) in patients with moderate to severe RA. Patients will be randomized to one of the
following study arms for 24 weeks:
- Treatment 1, Placebo: 2 tablets taken tid
- Treatment 2, MRC375: 1 tablet of 75 mg tetracycline HCL plus 1 matching placebo tablet
taken tid. Total daily dose = 225 mg.
- Treatment 3, MRC375: 2 tablets of 75 mg tetracycline HCL taken tid. Total daily dose =
450 mg.
Study medication should be taken within 30 minutes of a meal or light snack (either before
or after).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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