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NCT Number: NCT07008846

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Moderate to Severe Rheumatoid Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, Shahbag, 1000, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. DAS28-CRP

    Time frame: Outcome 1:"Disease Activity Score 28 CRP (DAS28-CRP) at week 4" Outcome 2:"Disease Activity Score 28 CRP (DAS28-CRP) at week 12" Outcome 3:"Disease Activity Score 28 CRP (DAS28-CRP) at week 24"

    Number of Participants with Low disease activity or Remission as Assessed by DAS28-CRP, Change from Baseline in Pain Scores on the Visual Analog Scale at 24Weeks).

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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