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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Baricitinib 2 MG; Drug: Baricitinib 4 MG Oral Tablet

Detailed Description

This open label randomized controlled clinical trial will be conducted in the department of Rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to severe disease activity (DAS 28 ESR/CRP>3.2) despite treatment with methotrexate or other csDMARDs will be considered as primary entry criteria for this study. Simple random sampling method will be applied. After a washout period of three weeks, Group A will be put on baricitinib 2 mg once daily and Group B will be put on baricitinib 4 mg once daily. Methotrexate 10mg will be used on both groups in addition to barcitinib. NSAIDs and adjuvant analgesics will be used if needed. All the patients will go through baseline evaluation before treatment which include-Disease Activity Score derivative for 28 joints (DAS 28ESR/CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and laboratory tests like CBC, CRP, SGPT, Serum Creatinine, LDH, RF, ACPA, Chest X-ray P/A view and TST or interferon gamma release assay (IGRA). Follow up will be done at 4th, 12th and 24th week. Response to treatment will be evaluated by DAS 28 ESR/CRP. Primary endpoint for efficacy will be assessed at the end of 24th week by DAS 28 CRP response. Secondary endpoints will be determined by SDAI, CDAI and HAQ-DI. Adverse effects will be assessed by history, physical examinations and investigations

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bangladesh
  • [Other]
    • Dhaka, [Other], Bangladesh, 1207
      • Dr. Md. Sadikul islam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization
2. Hemoglobin (Hb) < 8 g/dl
3. White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3
4. Live vaccines within 3 months prior to the first dose
5. Serum creatinine > upper limit of normal reference range
6. eGFR < 60 ml/minute/1.73 m2
7. Alanine transaminase (ALT) more than ULN
8. Pregnant or breast feeding females of child-bearing potential
9. 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
10. New York Heart Association Class III and IV congestive heart failure
11. Previous history of thromboembolism, deep venous thrombosis, diverticulitis

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baricitinib 2mg and methotrexate 10mg; Baricitinib 2mg once daily plus methotrexate 10mg per week	Drug: Baricitinib 2 MG; baricitinib 4mg once daily in group A; Other Names: for group A
Experimental: Baricitinib 4mg and methotrexate 10mg; Baricitinib 4mg once daily plus methotrexate 10mg per week	Drug: Baricitinib 4 MG Oral Tablet; baricitinib 4 mg once daily; Other Names: for group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical Disease activity index (CDAI)	clinical disease activity index at 6 months will be recorded. Score of equal or less than 10 will be regarded as low disease activity	6 months
Health Assessment Questionnaire-Disability Index (HAQ-DI)	health assesment by HAQ-DI at 6 months will be recorded. reduction of more than 0.22 will be regarded as improvement.	6 months

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Principal Investigator: Sadikul i sadik, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Ann Rheum Dis. 2017 Sep;76(9):1634.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: RA; baricitinib; JAKi
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: BSMMU/2022/11646

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