Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT07008846

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-10
• Study Completion Date: 2026-09-30

Brief Summary

The aim of this study is to assess the efficacy of upadacitinib, methotrexate combination therapy in comparison to tofacitinib, methotrexate combination therapy in moderate to severe RA patients. This study will guide us to treat RA patients with inadequate response to methotrexate more effectively

Conditions

Moderate to Severe Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Efficacy of upadacitinib, methotrexate combination therapy versus tofacitinib, methotrexate combinat

Group Type: EXPERIMENTAL

To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis

Intervention Type: DRUG

This intervention is open label. Both patient and investigator will know about the intervention. Participants are allocated according to block randomization. Total two groups with each contain 48 patients. One group will be given Tofacitinib, Methotrexate and another group will be given Upadacitinib, Methotrexate

Interventions

To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis

This intervention is open label. Both patient and investigator will know about the intervention. Participants are allocated according to block randomization. Total two groups with each contain 48 patients. One group will be given Tofacitinib, Methotrexate and another group will be given Upadacitinib, Methotrexate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1.Patients of both gender (age ≥18 years). 2.Patients fulfill the ACR/EULAR 2010 classification criteria for rheumatoid arthritis.

3.Patients with DAS-28 CRP >3.2 despite optimum dose and duration of methotrexate (20-25 mg/week for minimum one month).

Exclusion Criteria

• 1.Recent or concurrent infection

2.Active or latent tuberculosis

3. Hemoglobin (Hb) < 8 g/dl 4. White blood cell count < 4000/ micro L, Neutrophil count < 1000/ micro L, Platelet count < 100000/mm3 5. Live vaccines (rota virus, varicella, yellow fever) within 3 months prior to the first dose 6. Child-Pugh Class -C 7. Pregnant or planned for pregnancy and breastfeeding females of child-bearing potential 8. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ 9. New York Heart Association Class III and IV congestive heart failure 10. Previous history of thromboembolism, deep venous thrombosis, stroke, IHD

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Md Anisul Islam

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, Shahbag, Bangladesh

Countries

Bangladesh

Other Identifiers

5454

Identifier Type: -

Identifier Source: org_study_id