A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients
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
1 other identifier
interventional
300
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Nov 2011
Typical duration for phase_2 rheumatoid-arthritis
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 3, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMay 12, 2014
May 1, 2014
2.7 years
August 2, 2011
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy evaluated of both doses of MRC375 compared to placebo after 24 weeks of treatment as measured by the rate of achievement of 20% improvement in ACR criteria
evaluate efficacy of both doses of MRC375 compared to placebo after 24 weeks of treatment, as measured by a rate of achievement of 20% improvement in American College of Rheumatology (ACR) criteria (ACR20) at Week 24
24 weeks
Secondary Outcomes (2)
Safety and tolerability of both doses of MRC375
24 weeks
Compare the Efficacy of two doses of MRC375 when compared to a placebo for the change from baseline screening in each of the individual ACR components measuring RA after 24 weeks of treatment
24 weeks
Study Arms (3)
MRC375 75 mg
EXPERIMENTALMRC375 (enteric coated Tetracycline) 75 mg 3 times a day
MRC375 150mg
EXPERIMENTALMRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks.
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Is 18 years of age
- Is diagnosed with moderate to severe adult onset RA \> = 6 months duration, as defined by the 1987 ACR classification criteria
- Has moderate to severe RA as defined by:
- ≥4 tender joints/painful (28 joint count) at screening
- ≥4 swollen joints (28 joint count) at screening
- Has a Health Assessment Questionnaire (HAQ) of \>0
- Has a physician global assessment (Likert scale) of \>0
- Has a patient global assessment of pain (Likert scale) of \>0
- Has a patient assessment of pain (Likert scale) of \>0
- Has stable doses of the following allowable medications during the study, if applicable:
- Stable dose of NSAIDs or other analgesics for at least 2 weeks prior to administration of study drug at regulatory approved doses
- Stable dose of methotrexate 7.5 mg to 25 mg/day once weekly for at least 6 weeks prior to administration of study drug (no changes in dosing regimen for 4 weeks prior to screening)
- Stable dose of hydroxychloroquine either monotherapy or in combination with methotrexate 8 weeks prior to administration of study drug
- Is a non-pregnant, non-lactating female who is postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea
- If female of childbearing potential, must agree to use one of the following acceptable birth control methods:
- +8 more criteria
You may not qualify if:
- Has been diagnosed with any other inflammatory arthritis (eg, psoriatic arthritis)
- Has a secondary type of arthritis (eg, osteoarthritis) that would interfere with study evaluations
- Has taken the following drugs within the timeframe specified below:
- Infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the administration of study drug;
- Rituximab - Within 12 months prior to the administration of study drug;
- Disease-modifying antirheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: sulfasalazine, gold, leflunomide, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the administration of study drug;
- Any steroids (glucocorticoids); glucocorticoids must be discontinued for at least 4 weeks prior to administration of study drug. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to administration of study drug.
- Has a uncontrolled symptoms of fibromyalgia with sufficient symptoms requiring treatment (NOTE: patients on a stable dose of treatment for symptoms of fibromyalgia ≥ 4 weeks will be allowed in the study.)
- Has a history of allergic reaction to tetracycline or other related drugs
- Had major surgery or trauma within 28 days prior to screening
- Is concurrently using minocycline or doxycycline (washout of 4 weeks required before the administration of study drug)
- Patients who are on chronic antibiotics or who are on antibiotics for GI infections (such as Clostridium difficile)
- Has clinically significant ECG abnormalities
- Has any clinically significant abnormal laboratory test results found during medical screening including: AST or ALT \> 2 x upper limit of normal or serum creatinine \> 2.0 mg/dL
- Has clinically significant history or presence of any gastrointestinal pathology (eg, chronic diarrhea, inflammatory bowel disease, acute diverticulitis), irritable bowel syndrome, unresolved gastrointestinal symptoms (eg. diarrhea, vomiting, symptoms of acute diverticulitis), liver or kidney disease, gastric bypass, gastric stapling, use of Lap-Band®, or other conditions known to or which might interfere with the absorption, distribution, metabolism, or excretion of the drug
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Molecular Research Center, Inc.lead
- Camargo Pharmaceutical Servicescollaborator
- Clin Data Servicescollaborator
- Harrison Clinical Researchcollaborator
- BARC Global Central Laboratorycollaborator
- Bilcare Global Clinical Suppliescollaborator
Study Sites (19)
Mobile Diagnostic Center Rheumatology
Mobile, Alabama, 36608, United States
Valerius Medical Group
Long Beach, California, 90806, United States
Trial Concierge/Pacific Clinical Studies
Los Alamitos, California, 90720, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Global Clinical Professionals
Miami, Florida, 33156, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Lakeview Medical Research
Summerfield, Florida, 34491, United States
Analan Clinical Research
Lenexa, Kansas, 66219, United States
Trial Concierge
Owensboro, Kentucky, 42303, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Advanced BioMedical Research of America
Las Vegas, Nevada, 89123, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Providence Health Partners
Dayton, Ohio, 45439, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, 23185, United States
Apex Clinical Research
Kennewick, Washington, 99336, United States
South Puget Sound Clinical Research Center
Olympia, Washington, 98502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 3, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
May 12, 2014
Record last verified: 2014-05