A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients
NCT01408602 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2014-05-12
Summary
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.
Conditions
Interventions
- DRUG
-
MRC375
MRC 375 (enteric coated Tetracycline) 75mg 3 times a day for 24 weeks.
- DRUG
-
Matching Placebo
Matching Placebo 3 times a day for 24 weeks. Early escape at week 16,20.
- DRUG
-
MRC375 150mg
MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks
Sponsors & Collaborators
-
Camargo Pharmaceutical Services
collaborator INDUSTRY -
Clin Data Services
collaborator UNKNOWN -
Harrison Clinical Research
collaborator INDUSTRY -
BARC Global Central Laboratory
collaborator UNKNOWN -
Bilcare Global Clinical Supplies
collaborator UNKNOWN -
Molecular Research Center, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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