Arthritis, Rheumatoid Clinical Trial
Official title:
Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis
The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-joint pain. The investigators will also use data from the trial to determine whether response to milnacipran is associated with pain-modulating mechanisms from the central nervous system. The investigators hypothesize that response to milnacipran will be greater among patients with impaired central pain mechanisms than among patients with intact central pain modulating mechanisms.
Despite the development of effective medications to treat inflammation, pain remains a
priority for rheumatoid arthritis (RA) patients. The pain that persists despite
anti-inflammatory treatment is usually widespread and non-articular; it may lead to
diminished quality of life and high medical, psychological and social costs. To develop
better treatments for pain and prevent disability, it is critical to obtain a better
understanding of widespread, non-joint pain in RA.
Milnacipran is a selective serotonin-norepinephrine reuptake inhibitor (SNRI). No studies
have examined the effect of SNRIs on pain in RA. However, several studies have examined the
role of SNRIs in fibromyalgia and related pain conditions. Treatment with milnacipran has
been associated with improvements in clinical pain severity in Phase 2 and Phase 3
randomized placebo-controlled trials of fibromyalgia patients. In animal models, milnacipran
appears to moderate the pain-inducing effects of inflammation and central sensitization.
Thus milnacipran may be an ideal drug to treat pain in RA.
A clinical trial of an SNRI in the treatment of widespread, non-joint pain in RA will
provide more information regarding pain mechanisms and may lead to more targeted, effective
ways of treating pain in RA.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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