Rheumatoid ArthritisPhase 4NCT06146972
Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis
A Phase 4 study testing Iguratimod in people with Rheumatoid Arthritis and Therapy, run by Yanfeng Hou at 1 site in China.
Trial summary
Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Therapy
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 May 2024
- 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
- Male or female aged 18-65 years old
- Body weight not less than 40kg
- Patients with a clear diagnosis of rheumatoid arthritis (RA) who meet the diagnostic criteria for RA introduced by the ACR in 1987 or ACR\EULAR in 2010
- Joint function grade II-III
- Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ① ≥ 6 joints swollen [66 joints count]
- ② ≥ 6 joints tenderness [68 joints count]
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- ③Erythrocyte sedimentation rate (ESR) > 28 mm/h or C-reactive protein (CRP) > 1.0 mg/dL)
- The Patients have been treated with csDMARDs for ≥ 3 months and have been treated with stable doses of csDMARDs for 4 consecutive weeks prior to study entry, with poor therapeutic outcomes and are being considered for treatment with a combination of biologics (bDMARDs) (according to the 2018 China Rheumatoid Arthritis Treatment Guidelines, poor outcomes, i.e., no significant improvement in RA disease activity within 3 months or failure to achieve treatment goals within 6 months)
- Subjects must be able and willing to perform subcutaneous (SC) injections on their own, or a qualified person must be available to perform SC injections
- If taking glucocorticosteroids, prednisone should be ≤10mg or other hormone at a dose equivalent to prednisone and the dose should be kept constant for at least 28d
- Understand the purpose of the trial and the test procedures and sign a written informed consent form voluntarily
Who cannot join
- Patients who have used potent immunosuppressants (such as cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygiam glycosides and so on that affect the evaluation of efficacy in previous rheumatoid arthritis treatment , and who have stopped taking them for less than 4 weeks
- History of allergy to relevant test drugs
- Previously treated with bDMARDs
- Subject has recently received a live vaccine, or plans to use any live vaccine during the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yanfeng Hou
Jinan, Shandong, 250000
Yanfeng Hou, 15168888165, yfhou1016@163.com
About this study
Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.
Read the detailed description
This is an open, controlled, interventional clinical study enrolling patients with active RA who meet the following entry row criteria, and treating patients with IGU 25 mg bid + tofacitinib 5 mg bid for the intervention. The screening period was defined as the screening visit was conducted within 1 month prior to the baseline visit, and efficacy and safety assessments were performed at time points 0, 4, 12, 18, and 24 weeks from the time the subject was treated with the study protocol (see efficacy and safety endpoints for details), and study subjects were asked to come to the hospital for follow-up within ±3 days of the corresponding follow-up point.
- Conditions
- Rheumatoid Arthritis, Therapy
- Being tested
- Iguratimod
- 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 tofacitinib
Iguratimod 25mg bid + tofacitinib 5mg bid
| Study group | Role | What they receive |
|---|---|---|
| RF positive group | Experimental | Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. Receives: Drug: Iguratimod |
| RF negative group | Experimental | Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. Receives: Drug: Iguratimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20
ACR20 is the gold standard for the degree of disease remission in RA. The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥20%, and at least three of the following five parameters improved by ≥20%:① Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP).
Measured: 24 weeks
ACR50
The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥50%, and at least three of the following five parameters improved by ≥50%:① Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP).
Measured: 24 weeks
DAS28 (ESR)
Disease activity was assessed by calculating the DAS28 score; ≤2.6 was considered remission, >2.6 and ≤3.2 was considered low disease activity, >3.2 and ≤5.1 was considered moderate disease activity, and >5.1 was considered high disease activity.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jun 2021
- Primary completion24 Mar 2024 (estimated)
- Study completion31 May 2024 (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.
- 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
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanfeng Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanfeng Hou, Qianfoshan Hospital
- Investigators
- Yanfeng Hou, Dr., Study director, Yanfeng Hou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146972
- Sponsor's protocol ID
- GZPK2021Z0629
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2023
- Last updated
- 25 Mar 2024
- 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 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06146972
- Acronym / sponsor ID
- GZPK2021Z0629
- Conditions
- Rheumatoid Arthritis, Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Yanfeng HouUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 24 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 27 Nov 2023 (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.
Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.
Detailed description
This is an open, controlled, interventional clinical study enrolling patients with active RA who meet the following entry row criteria, and treating patients with IGU 25 mg bid + tofacitinib 5 mg bid for the intervention. The screening period was defined as the screening visit was conducted within 1 month prior to the baseline visit, and efficacy and safety assessments were performed at time points 0, 4, 12, 18, and 24 weeks from the time the subject was treated with the study protocol (see efficacy and safety endpoints for details), and study subjects were asked to come to the hospital for follow-up within ±3 days of the corresponding follow-up point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF positive group | Experimental | Drug: IguratimodIguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. |
| RF negative group | Experimental | Drug: IguratimodIguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged 18-65 years old
- Body weight not less than 40kg
- Patients with a clear diagnosis of rheumatoid arthritis (RA) who meet the diagnostic criteria for RA introduced by the ACR in 1987 or ACR\EULAR in 2010
- Joint function grade II-III
- Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ① ≥ 6 joints swollen [66 joints count]
Key exclusion criteria (4 listed)
- Patients who have used potent immunosuppressants (such as cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygiam glycosides and so on that affect the evaluation of efficacy in previous rheumatoid arthritis treatment , and who have stopped taking them for less than 4 weeks
- History of allergy to relevant test drugs
- Previously treated with bDMARDs
- Subject has recently received a live vaccine, or plans to use any live vaccine during the study
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: tofacitinibIguratimod 25mg bid + tofacitinib 5mg bid | Drug | RF negative group, RF positive group |
Primary outcome
ACR20
Time frame: 24 weeks
ACR20 is the gold standard for the degree of disease remission in RA. The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥20%, and at least three of the following five parameters improved by ≥20%:① Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP).
ACR50
Time frame: 24 weeks
The specifics are: according to the ACR criteria, the patient's joint tenderness count (TJC) and joint swelling count (SJC) improved by ≥50%, and at least three of the following five parameters improved by ≥50%:① Pain Visual Analog Scale (VAS) ② the Patient Global Assessment (PGA) ③ Physician Global Assessment (MDGA) ④ Health Assessment Questionnaire disability index (HAQ DI) score ⑤ Acute-phase reactants (ESR or CRP).
DAS28 (ESR)
Time frame: 24 weeks
Disease activity was assessed by calculating the DAS28 score; ≤2.6 was considered remission, >2.6 and ≤3.2 was considered low disease activity, >3.2 and ≤5.1 was considered moderate disease activity, and >5.1 was considered high disease activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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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.
Yanfeng Hou, Dr. study director
Yanfeng Hou
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 and Therapy, run by Yanfeng Hou 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 11 inclusion and 4 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 25 Mar 2024. 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. 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?
Contact Yanfeng Hou, Dr. (15168888165, yfhou1016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 (time frame: 24 weeks). The study lists 3 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 25 Mar 2024.