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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase

Active, not recruiting

Phase 3

Conditions

Moderate to Severe Rheumatoid Arthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07008846

5454

Details and patient eligibility

About

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

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
1. 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