Condition category
Musculoskeletal Diseases
Date applied
23/01/2019
Date assigned
06/02/2019
Last edited
30/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mihir Gharia

ORCID ID

http://orcid.org/0000-0001-8321-7966

Contact details

Zydus Tower
Satellite Cross Road
Gujarat
India
Ahmedabad
380015
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Exemptia Registry Protocol; Version 2.0

Study information

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).

Acronym

ASPIRE

Study hypothesis

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

Intersystem Biomedica Ethics Committee, 09/02/2018, ref. ISBEC/NR-3/DD-JJ/2018.

Study design

Observational, post marketing study

Primary study design

Observational

Secondary study design

Post marketing Study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

12/04/2015

Overall trial end date

30/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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.

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

1500

Participant 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

Recruitment start date

30/11/2015

Recruitment end date

30/11/2015

Locations

Countries of recruitment

India

Trial participating centre

Sarvajeet Pal
Apollo Hospitals Road Number 72, Landmark: Opposite to Bharatiya Vidya Bhavan School Lane & Near Film Nagar, Hyderabad Telangana
Hyderabad
500033
India

Trial participating centre

Manjari Agarwal
AC-52, Second Floor, Tagore Garden, -
New Delhi
110060
India

Trial participating centre

Ajit Nalawade
PAIN & ARTHRITIS CLINIC, F-204, Choice-A apartments, 38, Sassoon road, Near Ruby Hall Clinic,
Pune
410001
India

Trial participating centre

Vijay Rao
Divisha Arthritis and Medical Center, No- 500/A, 1st G Cross, 8th Main Road,4th Block, 3rd Stage, , Landmark: St. Mira's High School Basaveshwaranagar , Bangalore
Bangalore
560079
India

Trial participating centre

Smruti Ramteke
Jasleen Hospital, Opp. Big Bazar, Panchsheel Square, Dhantoli,
Nagpur
440001
India

Trial participating centre

Lalit Duggal
C-2/ 252, Janakpuri, New Delhi -
delhi
110058
India

Trial participating centre

Sanjeev Kapoor
Sanjivi Rheumatology and Infertility Centre C2-107, Kendriya Vidyalaya Road, Near Geeta Mandir, Janakpuri, New Delhi,
Delhi
110058
India

Trial participating centre

Anish Aggarwal
Brij Medical Centre KK-54, Kavi Nagar, Ghaziabad. (U.P.)
ghaziabad
110095
India

Trial participating centre

Firdaus Fatima
AB Rheumatology Centre 5-9-1032/A, Bhartiya Vidya Bhavan Rd, Gun Foundry, Basheer Bagh, Hyderabad, Telangana
hyderabad
500001
India

Trial participating centre

Biswadip Ghosh
Apex Institute Of Medical Sciences, 1219, Santoshpur, -
Kolkata
700075
India

Trial participating centre

Varsha Bagul
201, A Wing, 2nd Floor, Swapan Bhoomi Building, S K Bole Road, Above Bharat Bank, Nearby Portuguese Church, ,
Dadar West
400014
India

Trial participating centre

Shashank Akerkar
Mumbai Arthritis Clinic & Research Center WING-K, Lal Bahadur Shastri Rd, Rajiv Gandhi Nagar, Bhandup West, Mumbai, Maharashtra
Bhandup West, Mumbai,
400078
India

Trial participating centre

Neeraj Jain
10/75, 3rd Floor, Old Rajinder Nagar, New Delhi-110060
delhi
110060
India

Trial participating centre

Bimlesh Pandey
Fortis Hospital Noida B - 22, Sector 62, Gautam Buddh Nagar,
Noida
201009
India

Trial participating centre

Ashish Badika
House no 37 CH, Scheme 74C, Vijay nagar, Indore
Indore
25111
India

Trial participating centre

Lata Bichile
106, 1st Floor, Modi Chambers, Opera House, Mumbai - , Near French Bridge (Map)
mumbai
400004
India

Trial participating centre

Rahul jain
Jaipur Arthritis Centre H 7, Jan Path, Sector 10, Sector 6, Shyam Nagar, , Rajasthan
Jaipur
302019
India

Trial participating centre

Arindam Royl
Yashoda Hospital Alexander Road Secunderabad , Andhra Pradesh , India
secunderabad
500026
India

Trial participating centre

Raja Natarajan
13, C-Sector, Vgraonagar, Vellore, Tamil Nadu INDIA
vellore
632011
India

Trial participating centre

Viswanath Kaushik
Arthritis & Rheumatism Centre 17 Jambulingam Street Nungambakkam
Chennai
600034
India

Trial participating centre

Sujata Sawhney
Sir Ganga Ram Hospital Center for Child Health, Sir Ganga Ram Hospital, New Delhi, Delhi
delhi
110022
India

Trial participating centre

Krishnamurthy Venkataraman
Apollo Speciality Hospital 320,Anna Salai , Anna Salai Chennai -
Chennai
600035
India

Trial participating centre

Banwari Sharma
Plot No.4, Jharkhand Mor, Khatipura Road, Jaipur, Rajasthan
jaipur
302006
India

Trial participating centre

Shiva Prasad
Kuvempu Nagar 1st Stage, Kuvempu Nagara, Mysuru, Karnataka
Mysuru,
570008
India

Trial participating centre

Subramanian Nallasivan
Velammal Medical College Hospital & Research Institute, Rheumatology and Medicine, Madurai, Rheumatology and Medicine, Madurai
madurai
625001
India

Sponsor information

Organisation

Cadila Healthcare Ltd.

Sponsor details

Zydus Tower
Satellite Cross Road
Gujarat
India
Ahmedabad
380015
India

Sponsor type

Industry

Website

https://zyduscadila.com/

Funders

Funder type

Industry

Funder name

Cadila Healthcare Ltd.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement: 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.

Intention to publish date

31/01/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes