Rheumatoid ArthritisPhase 4NCT01893151
Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI
A Phase 4 study testing Iguratimod in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid 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
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2015
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- Rheumatoid Arthritis for 3 months to 2 years from the time of the initial diagnosis
- Functional Class II-III
- Subjects have active RA at the time of screening
- Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- Must have at least 4 tender joints and 4 swollen joints(involved in DAS28) and among these,at least one swollen Metacarpophalangeal joint is essential
- Has a C-reactive protein ≥ 10 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
- Written informed consent
Who cannot join
- Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), biological agents or tripterygium within 12 weeks prior to study entry
- Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc
- ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L or Cr >1.5mg
- WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- Subjects with serious cardiovascular, renal, hematologic,endocrine diseases or malignant
- Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
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- Pregnant, intend to become pregnant, or are breastfeeding
- Subjects with other rheumatological diseases such as SLE, mixed connective tissue disease, scleroderma, polymyositis, etc
- Subjects with inflammatory arthritis, such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease
- Subjects with intra-articular corticosteroid injections within 6 weeks prior to study entry
- Allergic to any of the study drugs
- History of alcoholism
- Subjects with mental illness
- Subjects receiving live vaccines recently
- Subjects participating in other clinical study within 3 months prior to study entry
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Gu, gujieruo@163.com
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)
The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).
Read the detailed description
Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression.
In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Iguratimod, Iguratimod placebo
- Keywords
- Iguratimod, MRI, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Also called Iremod
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
Iguratimod placeboDrug
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Experimental | Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week Receives: Drug: Iguratimod |
| Iguratimod placebo | Placebo comparator | Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week Receives: Drug: Iguratimod placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)
Measured: week 52
Change from baseline in modified Total Sharp Score (mTSS)
Measured: week 52
Percentage of patients with ACR 20 response
Measured: week 52
Change in Disease Activity as measured by the DAS28
Measured: week 52
Secondary outcomes (9)
Change from baseline in RAMRIS
Measured: week 24
Change from baseline in mTSS
Measured: week 24
Percentage of patients with ACR 20 response
Measured: week 10, week 24, week 40
Change from baseline in Disease Activity Score 28 (DAS28)
Measured: : week 10, week 24, week 40
Percentage of patients with ACR 50 response
Measured: week 10, week 24, week 40, week 52
Percentage of patients with ACR 70 response
Measured: week 10, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
Measured: week 10, week 24, week 40, week 52
Change from baseline in Simplified Disease Activity Index (SDAI)
Measured: week 10, week 24, week 40, week 52
Change from baseline in Health Assessment Questionnaire (HAQ)
Measured: week 10, week 24, week 40, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieruo Gu, Doctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893151
- Sponsor's protocol ID
- SMM-3
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT01893151
- Acronym / sponsor ID
- SMM-3
- Conditions
- Rheumatoid Arthritis
- Keywords
- Iguratimod, MRI, Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Jul 2013 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).
Detailed description
Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression.
In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.
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 | Experimental | Drug: IguratimodIguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week |
| Iguratimod placebo | Placebo comparator | Drug: Iguratimod placeboIguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- Rheumatoid Arthritis for 3 months to 2 years from the time of the initial diagnosis
- Functional Class II-III
- Subjects have active RA at the time of screening
- Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
Key exclusion criteria (15 listed)
- Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), biological agents or tripterygium within 12 weeks prior to study entry
- Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc
- ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L or Cr >1.5mg
- WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- Subjects with serious cardiovascular, renal, hematologic,endocrine diseases or malignant
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 |
|---|---|---|
| IguratimodAlso: IremodIguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week | Drug | Iguratimod |
| Iguratimod placeboIguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week. | Drug | Iguratimod placebo |
Primary outcome
Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)
Time frame: week 52
Change from baseline in modified Total Sharp Score (mTSS)
Time frame: week 52
Percentage of patients with ACR 20 response
Time frame: week 52
Change in Disease Activity as measured by the DAS28
Time frame: week 52
9 secondary outcomes
Change from baseline in RAMRIS
Time frame: week 24
Change from baseline in mTSS
Time frame: week 24
Percentage of patients with ACR 20 response
Time frame: week 10, week 24, week 40
Change from baseline in Disease Activity Score 28 (DAS28)
Time frame: : week 10, week 24, week 40
Percentage of patients with ACR 50 response
Time frame: week 10, week 24, week 40, week 52
Percentage of patients with ACR 70 response
Time frame: week 10, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
Time frame: week 10, week 24, week 40, week 52
Change from baseline in Simplified Disease Activity Index (SDAI)
Time frame: week 10, week 24, week 40, week 52
Change from baseline in Health Assessment Questionnaire (HAQ)
Time frame: week 10, week 24, week 40, week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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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.
Jieruo Gu, Doctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iguratimod in people with Rheumatoid Arthritis, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
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 8 inclusion and 15 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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS) (time frame: week 52). The study lists 4 primary outcomes in all. 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 23 Oct 2014.