Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

NCT05660655 | Completed Phase 4 DMC

• 1 other identifier: BSMMU/2022/11646
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.

Conditions

Rheumatoid Arthritis

Keywords

baricitinib; RA; JAKi

Outcome Measures

Primary Outcomes (1)

• Disease activity score 28-C-reactive protein (DAS28-CRP)

  Disease activity score in 28 joints has to measure at 6 months. score less than or equal 3.2 will be regarded as low disease activity

  6 months

Secondary Outcomes (3)

• Clinical Disease activity index (CDAI)

  6 months

• Health Assessment Questionnaire-Disability Index (HAQ-DI)

  6 months

• Disease activity score 28-C-reactive protein (DAS28-CRP)

  6 months

Study Arms (2)

Baricitinib 2mg and methotrexate 10mg

ACTIVE COMPARATOR

Baricitinib 2mg once daily plus methotrexate 10mg per week

Drug: Baricitinib 2 MG

Baricitinib 4mg and methotrexate 10mg

EXPERIMENTAL

Baricitinib 4mg once daily plus methotrexate 10mg per week

Drug: Baricitinib 4 MG Oral Tablet

Interventions

Baricitinib 4 MG Oral Tablet DRUG

baricitinib 4 mg once daily

Also known as: for group B

Baricitinib 4mg and methotrexate 10mg

Baricitinib 2 MG DRUG

baricitinib 4mg once daily in group A

Also known as: for group A

Baricitinib 2mg and methotrexate 10mg

Eligibility Criteria

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

You may qualify if:

• age greater than 18 years
• patients fulfill the ACR/EULAR 2010 classification criteria for RA
• DAS-28 CRP more than 3.2 despite optimum dose of methotrexate

You may not qualify if:

• Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization
• Hemoglobin (Hb) \< 8 g/dl
• White blood cell count \< 4000, Neutrophil count \< 1000, Platelet count \< 100000/mm3
• Live vaccines within 3 months prior to the first dose
• Serum creatinine \> upper limit of normal reference range
• eGFR \< 60 ml/minute/1.73 m2
• Alanine transaminase (ALT) more than ULN
• Pregnant or breast feeding females of child-bearing potential
• Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ
• New York Heart Association Class III and IV congestive heart failure
• Previous history of thromboembolism, deep venous thrombosis, diverticulitis

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Dr. Md. Sadikul islam

Dhaka, [Other], 1207, Bangladesh

Location

Related Publications (3)

• Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.

  PMID: 29415145 BACKGROUND

• 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: 27723271 RESULT

• Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, Beattie S, Witt S, de la Torre I, Gaich C, Rooney T, Schlichting D, de Bono S, Emery P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094. Epub 2016 Sep 29.

  PMID: 27689735 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Sadikul i sadik, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

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: Resident

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)