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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2020-09-30

Brief Summary

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It is a randomized controlled study

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Detailed Description

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

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label Randomization controlled clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

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 Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Methotrexate 25 mg subcutaneous is given in group A

group B

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

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

tofacitinib 10 mg given in group B

Interventions

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Methotrexate

Methotrexate 25 mg subcutaneous is given in group A

Intervention Type DRUG

Tofacitinib

tofacitinib 10 mg given in group B

Intervention Type DRUG

Other Intervention Names

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injection trexonate tofacit

Eligibility Criteria

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Inclusion Criteria

\-

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No