Assessing ExemptiaTM as a potential treatment for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Musculoskeletal Diseases; Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Juvenile Idiopathic Arthritis

• Registration Number: ISRCTN16838474
• Lead Sponsor: Cadila Healthcare Ltd.

Brief Summary

2019 results in patients with rheumatoid arthritis in: https://www.ncbi.nlm.nih.gov/pubmed/31254222 (added 09/07/2019) 2019 results in patients with ankylosing spondylitis in: https://www.ncbi.nlm.nih.gov/pubmed/31777828 (added 02/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-06
• Study Completion: 2019-11-30
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

1. =2 years up to 75 years old
2. Diagnosis as per current guidelines published by ACR/EULAR/CASPAR/ILAR guidelines of:
2.1. Rheumatoid Arthritis
2.2. Ankylosing Spondylitis
2.3. Psoriatic arthritis
2.4. Juvenile Idiopathic Arthritis (JIA)
3. Treatment with ExemptiaTM (Adalimumab)
4. Subjects and/or their parent/ legal guardian were willing to be contacted in the future by study staff.

Exclusion Criteria

1. Subjects receiving Adalimumab other than ExemptiaTM (Adalimumab)
2. Any contraindication for ExemptiaTM (Adalimumab) or concomitant drug like CNS and myeloid disorders according to Prescribing Information

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Timeframe: baseline, and week 24.<br> 1. Change in rheumatoid arthritis symptoms was measured using ACR20<br> 1.1. Swollen joint count<br> 1.2. Tender joint count and median of these 3 parameters ESR/VAS/PGA showing at least 20% improvement<br> 2. Disease Outcome Measures for RA & AS<br> 2.1. Reduction in DAS28 for RA<br> 2.1.1. Swollen joint count<br> 2.1.2. Tender joint count<br> 2.1.3. Patient global assessment<br> 2.1.4. Erythrocyte sedimentation rate<br> 2.2. Reduction in BASDAI for AS-Questionnaire based outcome measure<br> 3. Symptomatic improvement was measured using the reduction in pain VAS score.<br> 4. Inflammation was measured using the reduction in Acute Phase Reactants-ESR/CRP<br> 5. Tolerability was measured using patients 4 point assessment questionnaire<br>

Secondary Outcome Measures

Name	Time	Method
<br> Timeframe: baseline, and week 24.<br> 1. Change in rheumatoid arthritis symptoms was measured using ACR50, ACR70<br> 2. Disease severity was measured using physician global assessment<br> 3. Patient reported outcome was measured using patient global assessment<br> 4. Drug Safety was measured using:<br> 4.1. Frequency and severity of adverse events<br> 4.1.1. Adverse events as reported by the physician CIOMS form for serious AE<br> 4.2. Physical Examination<br> 4.3. Vital Signs<br> 4.4. Laboratory parameters<br>