title: Minocycline in rheumatoid arthritis. A 48-week, double-blind, placebo-controlled trial. MIRA Trial Group.
abstract: OBJECTIVE
  To assess the safety and efficacy of minocycline in the treatment of rheumatoid arthritis.
  
  
  METHODS
  A double-blind, randomized, multicenter, 48-week trial of oral minocycline (200 mg/d) or placebo.
  
  
  METHODS
  6 clinical centers in the United States.
  
  
  METHODS
  219 adults with active rheumatoid arthritis who had previous limited treatment with disease-modifying drugs.
  
  
  METHODS
  As the primary outcomes, 60 diarthrodial joints were examined for tenderness, and 58 joints were examined for swelling (hips excluded). Grip strength, evaluator's global assessment, morning stiffness, Modified Health Assessment Questionnaire, patient's global assessment, hematocrit, erythrocyte sedimentation rate, platelet count, and IgM rheumatoid factor levels were also assessed; radiographs of both hands and wrists were taken.
  
  
  RESULTS
  109 and 110 patients were randomly assigned to receive minocycline and placebo, respectively. At entry, demographic, clinical, and laboratory measurements were similar in both groups. Most patients had mild to moderate disease activity and some evidence of destructive disease. At the week 48 visit, 79% of the minocycline group and 78% of the placebo group continued to receive the study medication. At 48 weeks, more patients in the minocycline group than in the placebo group showed improvement in joint swelling (54% and 39%) and joint tenderness (56% and 41%) (P < 0.023 for both comparisons). The minocycline group also showed greater improvement in hematocrit, erythrocyte sedimentation rate, platelet count, and IgM rheumatoid factor levels (all P values < 0.001), and more patients receiving minocycline had laboratory values within normal ranges at 48 weeks. For the remaining outcomes, P values ranged from 0.04 to 0.76, all greater than the critical value of 0.005 (Bonferroni adjustment for multiple comparisons). The frequency of reported side effects was similar in both groups, and no serious toxicity occurred.
  
  
  CONCLUSIONS
  Minocycline was safe and effective for patients with mild to moderate rheumatoid arthritis. Its mechanisms of action remain to be determined.
authors.affiliation: Henry Ford Health Sciences Center, Detroit, Michigan.
authors.forename: B C
authors.initials: BC
authors.lastname: Tilley
authors.forename: G S
authors.initials: GS
authors.lastname: Alarcón
authors.forename: S P
authors.initials: SP
authors.lastname: Heyse
authors.forename: D E
authors.initials: DE
authors.lastname: Trentham
authors.forename: R
authors.initials: R
authors.lastname: Neuner
authors.forename: D A
authors.initials: DA
authors.lastname: Kaplan
authors.forename: D O
authors.initials: DO
authors.lastname: Clegg
authors.forename: J C
authors.initials: JC
authors.lastname: Leisen
authors.forename: L
authors.initials: L
authors.lastname: Buckley
authors.forename: S M
authors.initials: SM
authors.lastname: Cooper
authors.forename: H
authors.initials: H
authors.lastname: Duncan
authors.forename: S R
authors.initials: SR
authors.lastname: Pillemer
authors.forename: M
authors.initials: M
authors.lastname: Tuttleman
authors.forename: S E
authors.initials: SE
authors.lastname: Fowler
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000009:adverse effects / Q000627:therapeutic use*; D010349:Patient Compliance; D010352:Patient Dropouts; D011241:Prednisone / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D008911:Minocycline; D011241:Prednisone