NCT05827497

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

Rheumatoid Arthritis

Keywords

baricitinib, rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • DAS 28 ESR

    Following parameters are used to evaluate DAS28- Tender joint count Swollen joint count Patient global assessment (vas in cm) ESR/CRP

    24 weeks

Secondary Outcomes (2)

  • Clinical disease activity index (CDAI)

    24 weeks

  • Health assessment questionnaire disability index (HAQ-DI)

    24 weeks

Study Arms (2)

Group A

EXPERIMENTAL

baricitinib 2 mg once daily

Drug: Baricitinib 2 MG

Group B

ACTIVE COMPARATOR

methotrexate on 25 mg weekly

Drug: Methotrexate 25mg

Interventions

Baricitinib 2 MGDRUG

baricitinib 2 mg once daily

Also known as: Baricitinib 2mg
Group A
Methotrexate 25mgDRUG

25mg daily

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Md. Abu Shahin

Dhaka, Bangladesh

RECRUITING

Related Publications (3)

  • Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.

    PMID: 27723271BACKGROUND

  • Islam N, Baron Basak T, OudeVoshaar MA, Ferdous N, Rasker JJ, Atiqul Haq S. Cross-cultural adaptation and validation of a Bengali Health Assessment Questionnaire for use in rheumatoid arthritis patients. Int J Rheum Dis. 2013 Aug;16(4):413-7. doi: 10.1111/1756-185X.12032. Epub 2013 Jan 22.

    PMID: 23992261BACKGROUND

  • Yamaoka K. Janus kinase inhibitors for rheumatoid arthritis. Curr Opin Chem Biol. 2016 Jun;32:29-33. doi: 10.1016/j.cbpa.2016.03.006. Epub 2016 Mar 17.

    PMID: 26994322BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinibMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Dr. Md Abu Shahiin, FCPS, MD

    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Md Abu Shahin, FCPS, MD

CONTACT

+8801711313416abushahinrh@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Rheumatology

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)