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

NCT05216757 | Unknown Phase 2

• 1 other identifier: IGU-HOA
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

inflammatory hand osteoarthritis; iguratimod; a randomized control trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in patient's assessment of arthritis pain on a visual analogue scale

  Change from baseline in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome.

  12 weeks

Secondary Outcomes (8)

• Change from baseline in patient's assessment of arthritis pain on a visual analogue scale prior to each visit

  4 weeks, 8 weeks, 12 weeks

• Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) scores at each visit.

  4 weeks, 8 weeks, 12 weeks

• Change from baseline in Functional Index for Hand Osteoarthritis (FIHOA)

  12 weeks

• Change from baseline in Health Assessment Questionnaire Disability Index (HAQ)

  12 weeks

• Change from baseline in the Scores of SF-36 questionnaire

  12 weeks

Other Outcomes (7)

• Change from baseline in Erythrocyte Sedimentation Rate (ESR)

  12 weeks

• Change from baseline in C Reactive Protein (CRP)

  12 weeks

• Change from baseline in patient's global assessment of disease activity on a visual analogue scale

  12 weeks

Study Arms (2)

Iguratimod group

ACTIVE COMPARATOR

subjects with Iguratimod

Drug: Iguratimod

placebo group

PLACEBO COMPARATOR

subjects with placebo

Drug: placebo

Interventions

Iguratimod DRUG

iguratimod, 25mg bid po.

Iguratimod group

placebo DRUG

placebo 1 tablet bid po.

placebo group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients to be included must meet the following criteria:
• Age of 45-75 years.
• Men or women.
• Hand OA according to the ACR criteria.
• Symptomatic interphalangeal osteoarthritis for more than 3 months (at least every other day).
• At least 1 IPJ (DIP/PIP/IP1st) with soft tissue swelling or erythema.
• At least 1 IPJ with positive power Doppler signal or/and synovial thickening of at least grade 2 on ultrasound.
• Finger pain which was more than 40 mm as evaluated by visual analogue scales (VAS) (0-100 mm) in the preceding 48 hours.
• Be able to adhere to the study visit schedule and other protocol requirements. Capable of giving informed consent and the consent must be obtained prior to any screening procedures.

You may not qualify if:

• Other known medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, Lyme disease, Systemic lupus erythematosus, Sjogren Syndrome, Systemic sclerosis.
• Psoriasis.
• involving carpometacarpal \[CMC\] joints, without interphalangeal joints.
• Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder, poly-articular chondrocalcinosis, fibromyalgia).
• Trigger finger, injury in joints within past 6 months.
• Slow-acting drugs for OA (e.g. glucosamine, chondroitin, diacerhein) initiated within the previous 3 months before the study.
• Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before screening.
• Intra-articular corticosteroids into any joint or use of systemic corticosteroids 1 month before screening.
• Treatment with analgesics initiated within the previous 1 month and NSAIDs initiated within the previous 2 weeks.
• History of hand surgery within 12 months prior enrolment.
• Participation in experimental device or experimental drug study 3 months prior to enrolment.
• Scheduled surgery during study participation.
• Pregnant or lactating women，planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant.
• Known blood dyscrasias and coagulation disorders.
• Elevated alanine transaminase (AST/ALT \> 2x upper normal range).

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Arthritis

Interventions

iguratimod

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 31, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2022

Record last verified: 2022-01