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

NCT06146972 | Recruiting Phase 4

• 1 other identifier: GZPK2021Z0629
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Therapy

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  24 weeks

Study Arms (2)

RF positive group

EXPERIMENTAL

Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks.

Drug: Iguratimod

RF negative group

EXPERIMENTAL

Iguratimod (25mg per tablet) 25mg twice daily plus tofacitinib (5mg per tablet) 5mg twice daily for 24 weeks.

Drug: Iguratimod

Interventions

Iguratimod DRUG

Iguratimod 25mg bid + tofacitinib 5mg bid

Also known as: tofacitinib

RF negative group; RF positive group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[68 joints count\]
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yanfeng Hou: lead

Study Sites (1)

Yanfeng Hou

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod; tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yanfeng Hou, Dr.

  Yanfeng Hou

  STUDY DIRECTOR

Central Study Contacts

Yanfeng Hou, Dr.

CONTACT

15168888165; yfhou1016@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: November 27, 2023
• Study Start: June 1, 2021
• Primary Completion: March 24, 2024
• Study Completion: May 31, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CN (1)