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

Primary Purpose

Hand Osteoarthritis, Inflammatory Arthritis

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Iguratimod

placebo

About this trial

This is an interventional treatment trial for Hand Osteoarthritis focused on measuring inflammatory hand osteoarthritis, iguratimod, a randomized control trial

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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.

Exclusion Criteria:

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).
GRF (MDRD) < 60 mg/min/1.73m2.
Known viral hepatitis B or C.
Uncontrolled diseases, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
History of peptic ulcer.
Patients who have severe comorbidities, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease. Known any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iguratimod group

placebo group

Arm Description

subjects with Iguratimod

subjects with placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Differences in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 4 weeks, 8 weeks, and 12 weeks; higher value indicate worse outcome.

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

The AUSCAN Index is a self-administered questionnaire consisting of a 15-item scale which measures pain (5 items), stiffness (1 item) and degree of disability/physical function (9 items) during the preceding 48 hours; higher value indicate worse outcome.

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

The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment; higher value indicate worse outcome.

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

Change from baseline in Health Assessment Questionnaire Disability Index (HAQ) at week 12; higher value indicate worse outcome.

Change from baseline in the Scores of SF-36 questionnaire

Change from baseline in SF-36, including physical and mental component sores (PCS and MCS) at week 12; higher value indicate worse outcome.

Change from baseline in Michigan Hand Outcomes Questionnaire (MHOQ)

Michigan Hand Outcomes Questionnaire (MHOQ) pain and physical function subscales; function subscale range 10-50, higher value indicate worse outcome; task subscale range 17-85, higher value indicate worse outcome; work subscale range 5-25, higher value indicate worse outcome; pain subscale range 10-48, higher value indicate better outcome.

Change from baseline in Ultrasound record

Ultrasound record: number of finger joints with synovial thickening and power Doppler signals.

Change from baseline in OMERACT hand OA magnetic resonance imaging score

OMERACT hand OA magnetic resonance imaging score includes synovitis (0-3), erosive damage(0-3), cyst (0-3), osteophyte (0-3), cartilage space loss(0-3), malalignment (0-3), and bone marrow lesions (0-3); higher value indicate worse outcome

Full Information

NCT ID

NCT05216757

First Posted

January 7, 2022

Last Updated

February 7, 2022

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05216757

Brief Title

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

Acronym

ESIGO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2022 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Osteoarthritis, Inflammatory Arthritis

Keywords

inflammatory hand osteoarthritis, iguratimod, a randomized control trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iguratimod group

Arm Type

Active Comparator

Arm Description

subjects with Iguratimod

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

subjects with placebo

Intervention Type

Drug

Intervention Name(s)

Iguratimod

Intervention Description

iguratimod, 25mg bid po.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo 1 tablet bid po.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Differences in self-reported finger joint pain previous 48 hours on a 0-100 mm scale at 4 weeks, 8 weeks, and 12 weeks; higher value indicate worse outcome.

Time Frame

4 weeks, 8 weeks, 12 weeks

Title

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

Description

Time Frame

4 weeks, 8 weeks, 12 weeks

Title

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

Description

The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand OA-related functional impairment; higher value indicate worse outcome.

Time Frame

12 weeks

Title

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

Description

Change from baseline in Health Assessment Questionnaire Disability Index (HAQ) at week 12; higher value indicate worse outcome.

Time Frame

12 weeks

Title

Change from baseline in the Scores of SF-36 questionnaire

Description

Change from baseline in SF-36, including physical and mental component sores (PCS and MCS) at week 12; higher value indicate worse outcome.

Time Frame

12 weeks

Title

Change from baseline in Michigan Hand Outcomes Questionnaire (MHOQ)

Description

Time Frame

12 weeks

Title

Change from baseline in Ultrasound record

Description

Ultrasound record: number of finger joints with synovial thickening and power Doppler signals.

Time Frame

12 weeks

Title

Change from baseline in OMERACT hand OA magnetic resonance imaging score

Description

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Change from baseline in Erythrocyte Sedimentation Rate (ESR)

Description

Erythrocyte Sedimentation Rate (ESR); higher value indicate worse outcome.

Time Frame

12 weeks

Title

Change from baseline in C Reactive Protein (CRP)

Description

C Reactive Protein (CRP); higher value indicate worse outcome.

Time Frame

12 weeks

Title

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

Description

Change from baseline in patient's global assessment of disease activity previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome.

Time Frame

12 weeks

Title

Change from baseline of physician's global assessment of disease activity on a visual analogue scale

Description

Change from baseline in physician's global assessment of disease activity previous 48 hours on a 0-100 mm scale at 12 weeks of treatment; higher value indicate worse outcome.

Time Frame

12 weeks

Title

Change from baseline in Fingertip-to-palm distance

Description

Change from baseline in Fingertip-to-palm distance, cm

Time Frame

12 weeks

Title

Change from baseline in grip strength

Description

Change from baseline in grip strength, kg

Time Frame

12 weeks

Title

Swelling and Tender joint count, assessed by physician joint count

Description

Swelling and Tender joint count, assessed by physician joint count

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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. Exclusion Criteria: 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). GRF (MDRD) < 60 mg/min/1.73m2. Known viral hepatitis B or C. Uncontrolled diseases, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids. History of peptic ulcer. Patients who have severe comorbidities, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, GI disease. Known any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.

12. IPD Sharing Statement

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

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