Status and phase
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About
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.
Full description
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:
Study medication should be taken within 30 minutes of a meal or light snack (either before or after).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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:
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:
If female of childbearing potential, has a negative serum hCG pregnancy test at screening
Is able to swallow whole tablets of orally administered medication
Is able to understand and provide signed informed consent.
Exclusion criteria
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:
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
Has any historical or active neurological, endocrine, cardiovascular, pulmonary, hematological, psychiatric, or metabolic disease that is considered clinically significant by the Investigator
Has known history of HIV, hepatitis B or C (patients that have positive hepatitis B serology due to prior vaccination will be allowed in the study)
Has an active malignancy of any type or history of malignancy. Patients who have a history of a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma (ie. non melanoma skin cancer)and/or localized carcinoma in situ of the cervix are eligible. Patients with a history of other malignancies that have been treated and who have no evidence of recurrence for at least 5 years before study enrollment are also eligible.
Has difficulty swallowing tablets
Is ACR Functional Class IV (limited ability to perform usual self-care, vocational, and avocational activities)
Has known or suspected pregnancy, planned pregnancy, or lactation (for female patients)
Has clinically significant mental illness (to be determined by the Investigator)
Has a history in the last 2 years or current evidence of abuse of illicit drugs, prescription medications, or alcohol that, in the opinion of the Investigator, would interfere with adherence to study requirements. Has exposure to any investigational agent within 30 days prior to study entry.
Was previously enrolled in this study
Has recent history of bacterial intestinal tract infection (gastroenteritis, colitis, diverticulitis, appendicitis)
Has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
Primary purpose
Allocation
Interventional model
Masking
300 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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