Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

April 12, 2023 updated by: Md. Abu Shahin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer:

• Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This open-label randomized clinical trial will be conducted in the department of rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to high disease activity at baseline, disease activity score (DAS28ESR>3.2) will be considered as primary entry criteria for this study. Consecutive sampling method will be applied. The study will be done in 2 phases, duration of each phase 24 weeks. Considering inclusion and exclusion criteria, total 132 patients are randomized into group A and group B following block randomization. Each group will be consisting of 66 patients. In phase 1 Group A will be put on baricitinib 2 mg once daily and Group B will be put on methotrexate 25 mg weekly. The patients who fail to achieve remission or low disease activity by 24 weeks eligible for entry into phase 2 where group A will be put on baricitinib 4 mg and group B will be put on baricitinib 2 mg in combination with methotrexate 10 mg. Follow-up will be done at the 4th, 12th and 24th week in phase 1 and 28th, 36th and 48th week in phase 2. Response to treatment will be evaluated by DAS 28 ESR. At the end of 24th week endpoint for efficacy will be assessed at by DAS 28ESR. Adverse effects will be assessed by history, physical examinations and investigations.

Results will be compared among two groups with a 95% confidence interval and a p-value of < 0.05. The degrees of statistical significance between groups will be analyzed by unpaired t-test and/or Mann-Whitney U test. Qualitative data in between groups will be analyzed by the chi-square test. Probabilities of associations will be assessed by calculating Spearman´s rank correlation coefficient

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Recruiting
        • Dr. Md. Abu Shahin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Patients more than 18 years of age 2. Patients fulfill the ACR/EULAR 2010 classification criteria for Rheumatoid arthritis 3. Patients with DAS 28 ESR> 3.2

Exclusion Criteria:

  • 1. Recent or concurrent infection including active tuberculosis 2. Haemoglobin (Hb) < 9 gm/dl 3. Total WBC count < 4000 / µL 4. Neutrophil count < 1200 / µL 5. Lymphocyte count < 750 / µL 6. AST/ALT > three times the upper limit of normal 7. Estimated glomerular filtration rate < 60 ml/minute/1.73 m2 8. Co-morbid illness- e.g., Malignancy 9 . Pregnant or breast feeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
baricitinib 2 mg once daily
Drug: Baricitinib 2 MG
baricitinib 2 mg once daily
Other Names:
  • Baricitinib 2mg
Active Comparator: Group B
methotrexate on 25 mg weekly
Drug: Methotrexate 25mg
25mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS 28 ESR
Time Frame: 24 weeks
Following parameters are used to evaluate DAS28- Tender joint count Swollen joint count Patient global assessment (vas in cm) ESR/CRP
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical disease activity index (CDAI)
Time Frame: 24 weeks
Tender joint count Swollen joint count Patient global assessment (vas in cm) Physician global assessment (vas in cm)
24 weeks
Health assessment questionnaire disability index (HAQ-DI)
Time Frame: 24 weeks
The patient reports the amount of difficulty they have in performing some of these activities like Dressing and grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities. Each question asks on a scale ranging from 0 to 3. If the categories performed without any difficulty (scale 0) up to cannot be done at all (scale 3)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Dr. Md Abu Shahiin, FCPS, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSMMU/2022/10476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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