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

NCT04464642 | Unknown Phase 4 DMC

• 1 other identifier: BSMMU /2019/5499
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized controlled study

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis tofacitinib methotrexate

Outcome Measures

Primary Outcomes (1)

• DAS-28 CRP at 6 month

  disease activity score in 28 joints has to measured at 6 months

  6 months

Secondary Outcomes (2)

• SDAI at 6 months

  6 months

• HAQ-DI at 6 months

  6 months

Study Arms (2)

group A

EXPERIMENTAL

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

Drug: Methotrexate

group B

EXPERIMENTAL

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

Drug: Tofacitinib

Interventions

Methotrexate DRUG

Methotrexate 25 mg subcutaneous is given in group A

Also known as: injection trexonate

group A

Tofacitinib DRUG

tofacitinib 10 mg given in group B

Also known as: tofacit

group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Mohammad Mamun Khan: lead

Study Sites (1)

Bangabandhu Seikh Mujib Medical University

Dhaka, Bangladesh

Location

Related Publications (1)

• Khan MM, Ahmed S, Hasan Sajib MK, Morshed AA, Mahbub-Uz-Zaman K, Haq SA. Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial. Int J Rheum Dis. 2023 Sep;26(9):1729-1736. doi: 10.1111/1756-185X.14801. Epub 2023 Jun 28.

  PMID: 37377385 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohammad M Khan, MBBS

  Resident doctor, BSMMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident, BSMMU

Model Details: open label Randomization controlled clinical study

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: July 10, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)