Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis; Comparative Clinical Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 100
Study Overview
Brief Summary
The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. The main questions it aims to answer are:
- Which JAK inhibitor (Tofacitinib or Upadacitinib) is more effective to improve the disease activity of Rheumatoid arthritis in Pakistani population?
- What is the Disease Activity scores, ESR, CRP, RA factor level of patients?
- What are the side effects of both drugs, during the study time?
Participants:
- Of Group A will be taking 5mg Tofacitinib oral daily for 6 months along with 25mg of once weekly dose of oral Methotrexate, whereas of Group B will be taking 15mg Upadacitinib oral daily for 6 months along with 25mg of once weekly dose of oral methotrexate.
- Will Visit the clinic once at 3 months and then 6 months for checkups and tests
- Will Keep a diary of any infection, treatment taken, duration of infection
- Will inform the researcher about any unusual side effect during the study
Detailed Description
This study will be conducted in the Department of Pharmacology in collaboration with Rheumatology Department of Shaikh Zayed Medical Complex, Lahore.
The study population will consist of adult patients with diagnosis of RA on the basis of EULAR 2010 Classification Criteria: Moderate to severe disease activity indicated by DAS28 >3.2 and those with Inadequate response to methotrexate (MTX) characterized by Persistent active disease on ≥12 weeks of MTX treatment.
Sample size was estimated considering the following clinically significant variables: infection rate, thrombotic events, and cessation of treatment as a result of remission according to scientific publications. The maximum sample size was estimated among these methods in order to have adequate power.
If infection rate was considered as a key safety parameter, and taking into account the event rates of 0.7 and 1.2 per 100 patient-years for Tofacitinib and Upadacitinib, respectively22, the sample size would be 116 patients (58 per group) at 95% confidence interval and 80% power. In the case of thrombotic events with an assumed event rate of 0.2 and 0.4 per 100 patient-years23, the required sample size would be 100 patients (50 per group) at 95% confidence interval and 90% power.
Adult patients aged ≥18 years, regardless of gender will be included in the study. Whereas the following patients will not be included:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Adult patients aged ≥18 years, regardless of gender
Exclusion Criteria
- •• Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
- •Administration of any biologic DMARD in the previous three months
- •History of a serious infection (e.g., active tuberculosis or sepsis)
- •Previous or existing history of recurrent infections or immunosuppressive status
- •History of any malignancy in the last five years.
- •Current chemotherapy, radiotherapy or intake of any genotoxic drug
- •Severe liver impairment (e.g., ALT/AST >3× ULN)
- •Severe renal impairment (e.g., estimated GFR <30 mL/min)
- •Severe Haematological Abnormalities: Hb <8 g/dL, TLC <3,000 /mm³, Platelets <100,000 /mm³
- •Past or present deep vein thrombosis or pulmonary embolism
- •Pregnant or lactating women
- •Women of reproductive age who are not practicing adequate contraception measures
Investigators
Tahira Shaukat
Dr Sadia Maqsood Awan, Assistant professor
Sheikh Zayed Federal Postgraduate Medical Institute