Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146972
• Other study ID #: GZPK2021Z0629
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Qianfoshan Hospital
• Contact: Yanfeng Hou, Dr.
• Phone: 15168888165
• Email: yfhou1016[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 order to better inform the clinical management.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: May 31, 2024
• Est. primary completion date: March 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female aged 18-65 years old

2. Body weight not less than 40kg

3. 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

4. Joint function grade II-III

5. Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ? = 6 joints swollen [66 joints count] ? = 6 joints tenderness [68 joints count] ?Erythrocyte sedimentation rate (ESR) > 28 mm/h or C-reactive protein (CRP) > 1.0 mg/dL)

6. 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)

7. 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

8. 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

9. Understand the purpose of the trial and the test procedures and sign a written informed consent form voluntarily

Exclusion Criteria:

1. 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

2. History of allergy to relevant test drugs

3. Previously treated with bDMARDs

4. Subject has recently received a live vaccine, or plans to use any live vaccine during the study

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Therapy

Intervention

Drug:
• Iguratimod
Iguratimod 25mg bid + tofacitinib 5mg bid

Locations

Country	Name	City	State
China	Yanfeng Hou	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanfeng Hou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%:? Pain Visual Analog Scale (VAS) ? the Patient Global Assessment (PGA) ? Physician Global Assessment (MDGA) ? Health Assessment Questionnaire disability index (HAQ DI) score ? Acute-phase reactants (ESR or CRP).	24 weeks
Primary	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%:? Pain Visual Analog Scale (VAS) ? the Patient Global Assessment (PGA) ? Physician Global Assessment (MDGA) ? Health Assessment Questionnaire disability index (HAQ DI) score ? Acute-phase reactants (ESR or CRP).	24 weeks
Primary	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.	24 weeks