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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04464642

Enrollment

110

Registered

2020-07-09

Start date

2019-07-10

Completion date

2020-09-30

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis tofacitinib methotrexate

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

Interventions

DRUGMethotrexate

Methotrexate 25 mg subcutaneous is given in group A

DRUGTofacitinib

tofacitinib 10 mg given in group B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

open label Randomization controlled clinical study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
DAS-28 CRP at 6 month	6 months	disease activity score in 28 joints has to measured at 6 months

Secondary

Measure	Time frame	Description
SDAI at 6 months	6 months	simplified disease activity index at 6 months
HAQ-DI at 6 months	6 months	health assesment by HAQ-DI at 6 months

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026