Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: Tofacitinib

• Registration Number: NCT04464642
• Lead Sponsor: Dr. Mohammad Mamun Khan

Brief Summary

It is a randomized controlled study

Detailed Description

Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib

Study Timeline

• Study Start: 2019-07-10
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2020-08
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. age greater than 18 years 2. patients fulfill the ACR-EULAR classification criteria for RA 3.DAS-28 CRP more than 5.1

Exclusion Criteria

1. systemic infection
2. hemoglobin less than 9 mg/dl
3. WBC <4000, neutrophil <1000, platelet <100000/mm
4. live vaccine within 3 months
5. GFR < 50 ml/min
6. ALT > 2 times ULN
7. pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Methotrexate	group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs
group B	Tofacitinib	group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months

Primary Outcome Measures

Name	Time	Method
DAS-28 CRP at 6 month	6 months	disease activity score in 28 joints has to measured at 6 months

Secondary Outcome Measures

Name	Time	Method
HAQ-DI at 6 months	6 months	health assesment by HAQ-DI at 6 months
SDAI at 6 months	6 months	simplified disease activity index at 6 months

Trial Locations

Locations (1)

Bangabandhu Seikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh