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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Baricitinib 2 MG; Drug: Baricitinib 4 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05660655

BSMMU/2022/11646

Details and patient eligibility

About

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.

Full 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

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Baricitinib 2mg and methotrexate 10mg

Active Comparator group

Description:

Baricitinib 2mg once daily plus methotrexate 10mg per week

Treatment:

Drug: Baricitinib 2 MG

Baricitinib 4mg and methotrexate 10mg

Experimental group

Description:

Baricitinib 4mg once daily plus methotrexate 10mg per week

Treatment:

Drug: Baricitinib 4 MG Oral Tablet