Moderate to Severe Rheumatoid Arthritis
Conditions
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
Interventions
DRUGTo 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
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS28-CRP | 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). |
Countries
Bangladesh
Outcome results
None listed