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

NCT ID: NCT05660655

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-09-30

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.

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baricitinib 2mg and methotrexate 10mg

Baricitinib 2mg once daily plus methotrexate 10mg per week

Group Type: ACTIVE_COMPARATOR

Baricitinib 2 MG

Intervention Type: DRUG

baricitinib 4mg once daily in group A

Baricitinib 4mg and methotrexate 10mg

Baricitinib 4mg once daily plus methotrexate 10mg per week

Group Type: EXPERIMENTAL

Baricitinib 4 MG Oral Tablet

Intervention Type: DRUG

baricitinib 4 mg once daily

Interventions

Baricitinib 4 MG Oral Tablet

baricitinib 4 mg once daily

Intervention Type: DRUG

Baricitinib 2 MG

baricitinib 4mg once daily in group A

Intervention Type: DRUG

Other Intervention Names

for group B; for group A

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Md. Sadikul islam

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadikul i sadik, MBBS

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Dr. Md. Sadikul islam

Dhaka, [Other], Bangladesh

Countries

Bangladesh

References

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.

Reference Type: BACKGROUND

PMID: 29415145 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27723271 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27689735 (View on PubMed)

Other Identifiers

BSMMU/2022/11646

Identifier Type: -

Identifier Source: org_study_id