NCT05216757

Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO)

Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) : a Randomized Control Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hand osteoarthritis is one of the most common arthritis, resulting in pain in finger and thumb base joints. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. Currently limited therapy options are available. Synovial inflammation is involved in the joint pain. Iguratimod is a small disease-modifying compound that can influence anti-inflammatory pathways in models of rheumatoid arthritis. It has an anabolic effect on the bone metabolism of infected joint by osteoclastogenesis inhibition and osteoblast differentiation. The investigators hypothesize that Iguratimod will alleviate pain of patient with inflammatory hand osteoarthritis, and that a beneficial effect of Iguratimod on pain will be accompanied by a decrease of synovial inflammation.

Conditions

• Hand Osteoarthritis
• Inflammatory Arthritis

Interventions

Type	Name	Description
DRUG	Iguratimod	iguratimod, 25mg bid po.
DRUG	placebo	placebo 1 tablet bid po.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-01-31
• Last updated: 2022-02-08