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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 4
Locations
Bangladesh
Study Type
Interventional
Intervention
Methotrexate
Tofacitinib
Sponsored by
Dr. Mohammad Mamun Khan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis tofacitinib methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bangabandhu Seikh Mujib Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group B

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2020
Last Updated
July 6, 2020
Sponsor
Dr. Mohammad Mamun Khan
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1. Study Identification

Unique Protocol Identification Number
NCT04464642
Brief Title
Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
Official Title
Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Mohammad Mamun Khan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis tofacitinib methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
open label Randomization controlled clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm 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
Arm Title
group B
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
injection trexonate
Intervention Description
Methotrexate 25 mg subcutaneous is given in group A
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Other Intervention Name(s)
tofacit
Intervention Description
tofacitinib 10 mg given in group B
Primary Outcome Measure Information:
Title
DAS-28 CRP at 6 month
Description
disease activity score in 28 joints has to measured at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
SDAI at 6 months
Description
simplified disease activity index at 6 months
Time Frame
6 months
Title
HAQ-DI at 6 months
Description
health assesment by HAQ-DI at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: systemic infection hemoglobin less than 9 mg/dl WBC <4000, neutrophil <1000, platelet <100000/mm live vaccine within 3 months GFR < 50 ml/min ALT > 2 times ULN pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad M Khan, MBBS
Organizational Affiliation
Resident doctor, BSMMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Seikh Mujib Medical University
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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