Assessing ExemptiaTM as a potential treatment for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis
| ISRCTN | ISRCTN16838474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16838474 |
| Secondary identifying numbers | Exemptia Registry Protocol; Version 2.0 |
- Submission date
- 23/01/2019
- Registration date
- 06/02/2019
- Last edited
- 02/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Adalimumab is a fully human IgG1 monoclonal antibody with high specificity for TNF. Adalimumab (HUMIRA), the fully human anti-TNF alpha monoclonal antibody, was first approved globally in 2002 and has since then been the most preferred therapy to treat patients suffering from auto immune disorders. However, the therapy was not available to patients in India.
In India, Cadila Healthcare Limited has developed a biosimilar of Adalimumab (ExemptiaTM). ExemptiaTM(Adalimumab) has received marketing approval on 9th December 2014 to prescribe for the treatments of Rheumatoid arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Hidradenitis Suppurativa and Plaque Psoriasis.
Biosimilars have a similar level of efficacy and safety compared to that of the originator products and provide additional advantage to patients in terms of affordability and accessibility.
The main objective of this ASPIRE registry is to develop and maintain a robust patient registry/repository in order:
1. To evaluate the efficacy and safety of ExemptiaTM (Adalimumab) in patients suffering with Rheumatoid arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Juvenile Idiopathic Arthritis.
2. To provide and further strengthen the evidence base for ExemptiaTM (Adalimumab) to benefit patients suffering from such rheumatic disorders.
Who can participate?
Participants are Both male or female patient ≥2 years or upto 75 years diagnosis with Rheumatoid Arthritis (RA)/Ankylosing Spondylitis (AS)/Psoriatic arthritis (PsA)/Juvenile Idiopathic Arthritis (JIA) as per speciality physician judgement and have been prescribed Exemptia
What does the study involve?
A total 1500 patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis who are deemed fit as per screening requirements to be started on Exemptia therapy. Those who give consent to enroll in study would be followed up as per the physician recommendations while on therapy and 6 months post therapy stoppage. While on therapy and post the therapy stoppage the lab tests ordered by physician in his routine practice shall be collected during follow ups. Only the routine investigations ordered by physician for each indication would be ordered and no special tests would be ordered for this study.
Standard Adalimumab (Exemptia) 40 mg every other week dosing regimen will be given to the patients.
All the patients will be assessed for disease activity, change in rheumatic disease symptoms, Inflammation, pain, physical function and health assessment using various tools.
Safety of patients would be monitored with Side effect profile basis regular tests and monitoring by physician.
What are the possible benefits and risks of participating?
The possible benefit of participating is that the Adalimumab biosimilar (Exemptia) can be as effective as its originator. There are no known risks to participants, and they will be monitored for any side effects through routine physical and laboratory examinations every 3 months.
Where is the study run from?
The study will be conducted various research centers across India.
When is the study starting and how long is it expected to run for?
30/11/2015 to 30/11/2019
Who is funding the study?
The study is funded by Cadila Healthcare limited Ahmedabad.
Who is the main contact?
Dr Mihir Gharia
mihir10584@gmail.com
Contact information
Scientific
Zydus Tower
Satellite Cross Road
Gujarat, India
Ahmedabad
380015
India
 ORCID ID |
0000-0001-8321-7966 |
|---|
Study information
| Study design | Observational, post marketing study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Post marketing Study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | 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). |
| Study acronym | ASPIRE |
| Study objectives | The main objective of this ASPIRE registry is to develop and maintain a robust patient registry/repository in order: 1. To evaluate the efficacy and safety of ExemptiaTM (Adalimumab) in patients suffering with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. 2. To provide and further strengthen the evidence base for ExemptiaTM (Adalimumab) to benefit patients suffering from such rheumatic disorders. |
| Ethics approval(s) | Intersystem Biomedica Ethics Committee, 09/02/2018, ref. ISBEC/NR-3/DD-JJ/2018. |
| Health condition(s) or problem(s) studied | Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Juvenile Idiopathic Arthritis |
| Intervention | 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 physician’s setting. The physician prescribes Adalimumab Bisoimilar for treatment duration as per his choice (which happens with biologics in India since they are used as for short duration because of cost concerns). Since there is no intervention to normal clinical practice, the observations were recorded of their different parameters whenever the physician requested them for follow up visits. This enables a free non formalized way of data collection and real world experience. The observations and values are captured as long as patient comes for follow up while on therapy and 6 months post discontinuation of therapy. ExemptiaTM (Adalimumab) 40 mg every other other week(q2wk) via subcutaneous route as per the prescribing information of ExemptiaTM(Adalimumab) in case of Adults and For ≥2 years 10 kg to <15 kg: 10 mg SC q2wk 15 kg to <30 kg: 20 mg SC q2wk ≥30 kg: 40 mg SC q2wk Baseline and follow-up data will be captured at least for 2, 4, 8, 12, 16, 24, 52 week ± 1. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 12/04/2015 |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 1500 |
| Total final enrolment | 149 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 30/11/2015 |
| Date of final enrolment | 30/11/2015 |
Locations
Countries of recruitment
- India
Study participating centres
Hyderabad
500033
India
New Delhi
110060
India
Pune
410001
India
Bangalore
560079
India
Nagpur
440001
India
delhi
110058
India
Delhi
110058
India
ghaziabad
110095
India
hyderabad
500001
India
Kolkata
700075
India
Dadar West
400014
India
Bhandup West, Mumbai
400078
India
delhi
110060
India
Noida
201009
India
Indore
25111
India
mumbai
400004
India
Jaipur
302019
India
secunderabad
500026
India
vellore
632011
India
Chennai
600034
India
delhi
110022
India
Chennai
600035
India
jaipur
302006
India
Mysuru
570008
India
madurai
625001
India
Sponsor information
Industry
Zydus Tower
Satellite Cross Road
Gujarat, India
Ahmedabad
380015
India
| Website | https://zyduscadila.com/ |
|---|---|
"ROR" |
https://ror.org/03ktyvw44 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Data on effectiveness of biosimilar adalimumab in ankylosing spondylitis and Rheumatoid Arthritis will be ready to publish till January 2019. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Karmic Lifesciences LLP (dhiraj.patel@karmiclifesciences.com). The data available will be output analyzed data and will be available from 1st March 2019 for 3 months. Data is available for any analyses by written email request to be shared with only healthcare practitioners. Consent was obtained from participants and data is anonymised. The data is ethically approved and legal restriction for countries where approval for drug is not there. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results in patients with rheumatoid arthritis | 01/09/2019 | 09/07/2019 | Yes | No |
| Results article | results in patients with ankylosing spondylitis | 12/08/2019 | 02/12/2019 | Yes | No |
Editorial Notes
02/12/2019: Publication reference added.
09/07/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
