Faculty Opinions recommendation of Triple therapy in early active rheumatoid arthritis: a randomized, single-blind, controlled trial comparing step-up and parallel treatment strategies.

2008 ◽  
Author(s):  
Yusuf Yazici
Keyword(s):  
Rheumatoid Arthritis ◽  
Triple Therapy ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Single Blind

scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial

2018 ◽  
Vol 77 (4) ◽  
pp. 495-499 ◽  
Author(s):  
Ronald F van Vollenhoven ◽  
Edward Clark Keystone ◽  
Vibeke Strand ◽  
Cesar Pacheco-Tena ◽  
Jiří Vencovský ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Biological Activity ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Registration Number ◽  
Dose Dependent ◽  
Acr20 Response Rate

ObjectiveTo evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX).Methods321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200 mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment. After 24 weeks, patients could continue treatment with tregalizumab for 24 weeks (extension phase). The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Safety and biological activity were monitored through week 48.ResultsAt week 12, ACR20 response rates were not statistically significantly different between placebo and any of the tregalizumab doses. Tregalizumab injections were well tolerated; most adverse events were mild to moderate and comparable among treatment and placebo groups. Biological activity was shown by dose-dependent CD4 downmodulation.ConclusionTreatment with tregalizumab did not show significant clinical efficacy in patients with active RA compared with placebo but resulted in the expected biological effect on CD4 modulation. Tregalizumab was generally well tolerated, and no new safety findings were identified.Trial registration numberNCT01999192; Results.

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