Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Dextromethorphan hydrobromide

Registration Number: NCT02368093

Lead Sponsor: Taichung Veterans General Hospital

Brief Summary: Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (DMARDs). Disease activity were assessed.

Detailed Description: Biologic-naïve rheumatoid arthritis (RA) patients who fulfilled the 2010 criteria of the American College of Rheumatology (ACR) for RA were enrolled. All patient were randomized to a 6-month treatment with either oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan) with T1/2 = 7.75h, Tmax = 4.83h, Cmax = 14.6 ng mL-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast\] or placebo pills with the same appearance as DXM tablets. The randomization was performed by the pharmacy of the Taichung Veterans General Hospital. Non-study medications were not changed during the course of study.

Twenty-four patients received add-one DXM therapy and the other 24 patients received traditional DMARDs alone in stable dose. Disease activity was assessed by the 28-joint disease activity score (DAS28) before starting add-on DXM therapy (as a baseline) and at the end of 6 months of therapy with or without add-on DXM. Patients were categorized as good, moderate or poor responders based on the amount of change in the DAS28 and the level of DAS28 reached. Good responders were defined as patients who had a decrease in DAS28 from baseline (∆DAS28)\>1.2 and a DAS28≦3.2 at evaluation time; moderate responders had either ∆DAS28\>1.2 and a DAS28\>3.2 or ∆DAS28 of 0.6-1.2 and a DAS28≦5.1 at evaluation time; and poor responders were those who had either ∆DAS28\<0.6 or a DAS28\>5.1 at evaluation time.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA

Exclusion Criteria

Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextromethorphan hydrobromide	Dextromethorphan hydrobromide	Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast\]

Primary Outcome Measures