Hand OsteoarthritisPhase 2/3ESIGONCT05216757
Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO)
A Phase 2/3 study testing Iguratimod in people with Hand Osteoarthritis and Inflammatory Arthritis, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Hand Osteoarthritis, Inflammatory Arthritis
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) : a Randomized Control Trial
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
- Being tested
- Iguratimod, placebo
- Keywords
- inflammatory hand osteoarthritis, iguratimod, a randomized control trial
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
iguratimod, 25mg bid po.
placeboDrug
placebo 1 tablet bid po.
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod group | Active comparator | subjects with Iguratimod Receives: Drug: Iguratimod |
| placebo group | Placebo comparator | subjects with placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: 4 weeks, 8 weeks, 12 weeks
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.
Measured: 4 weeks, 8 weeks, 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Change from baseline in Ultrasound record
Ultrasound record: number of finger joints with synovial thickening and power Doppler signals.
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216757
- Sponsor's protocol ID
- IGU-HOA
- Acronym
- ESIGO
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Iguratimod in Patients With Hand Osteoarthritis (ESIGO) : a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05216757
- Acronym / sponsor ID
- ESIGO / IGU-HOA
- Conditions
- Hand Osteoarthritis, Inflammatory Arthritis
- Keywords
- inflammatory hand osteoarthritis, iguratimod, a randomized control trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iguratimod group | Active comparator | Drug: Iguratimodsubjects with Iguratimod |
| placebo group | Placebo comparator | Drug: placebosubjects with placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iguratimodiguratimod, 25mg bid po. | Drug | Iguratimod group |
| placeboplacebo 1 tablet bid po. | Drug | placebo group |
Primary outcome
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale
Time frame: 12 weeks
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.
8 secondary outcomes
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale prior to each visit
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) scores at each visit.
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in Functional Index for Hand Osteoarthritis (FIHOA)
Time frame: 12 weeks
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ)
Time frame: 12 weeks
Change from baseline in the Scores of SF-36 questionnaire
Time frame: 12 weeks
Change from baseline in Michigan Hand Outcomes Questionnaire (MHOQ)
Time frame: 12 weeks
Change from baseline in Ultrasound record
Time frame: 12 weeks
Change from baseline in OMERACT hand OA magnetic resonance imaging score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iguratimod in people with Hand Osteoarthritis and Inflammatory Arthritis, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in patient's assessment of arthritis pain on a visual analogue scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.