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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04464642
• Other study ID #: BSMMU /2019/5499
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 10, 2019
• Est. completion date: September 2020

Study information

• Verified date: July 2020
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a randomized controlled study

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
Methotrexate 25 mg subcutaneous is given in group A
• Tofacitinib
tofacitinib 10 mg given in group B

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Seikh Mujib Medical University	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Mohammad Mamun Khan

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS-28 CRP at 6 month	disease activity score in 28 joints has to measured at 6 months	6 months
Secondary	SDAI at 6 months	simplified disease activity index at 6 months	6 months
Secondary	HAQ-DI at 6 months	health assesment by HAQ-DI at 6 months	6 months