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

Post-marketing observational study to follow-up patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis who are treated with ExemptiaTM (Adalimumab).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16838474

Enrollment

1500

Registered

2019-02-06

Start date

2015-11-30

Completion date

Unknown

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Juvenile Idiopathic Arthritis Musculoskeletal Diseases Rheumatoid Arthritis

Interventions

This is a real world observational study in which patients at different centers post their diagnosis of either of IMID’s and starting of Exemptia as a therapy to them, come for follow up as per the ph

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026