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

Dr. Mohammad Mamun Khan

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04464642

BSMMU /2019/5499

Details and patient eligibility

About

It is a randomized controlled study

Full 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

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

group A

Experimental group

Description:

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

Treatment:

Drug: Methotrexate

group B

Experimental group

Description:

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

Treatment:

Drug: Tofacitinib