| CTRI Number |
CTRI/2019/10/021723 [Registered on: 18/10/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
APREMEPSa study: A comparative study between Apremilast and Methotrexate regarding their efficacy in psoriatic arthritis |
|
Scientific Title of Study
|
Comparison between Methotrexate and Apremilast in psoriatic arthritis: A single blinded randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joydeep Samanta |
| Designation |
DM-Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Clinical Immunology & Rheumatology Wing, Department of Internal Medicine, 4th Floor, C block, Nehru Hospital, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9836594064 |
| Fax |
|
| Email |
samantajoydeep@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aman Sharma |
| Designation |
Professor, Dept. of Internal Medicine |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Dept. of Internal Medicine, 4th Floor, C block, Nehru Hospital, Sector 12, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009681 |
| Fax |
|
| Email |
amansharma74@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Joydeep Samanta |
| Designation |
DM-Senior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Sector 12, PGIMER, Chandigarh
Dept of Internal Medicine, 4th Floor, F block, Nehru hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9836594064 |
| Fax |
|
| Email |
samantajoydeep@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joydeep Samanta |
PGIMER |
PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9836594064
samantajoydeep@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M07||Enteropathic arthropathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Apremilast |
Apremilast starting at dose of 10 mg daily 0rally and increasing the dose by 10 mg daily starting from day 2 to 30 mg twice daily orally . Total duration of study period is 24 weeks. |
| Comparator Agent |
Methotrexate |
Methotrexate starting at 15 mg/week orally and gradually increasing dose as per requirement upto maximum of 25 mg/week. Total duration of study period is 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years.
2. Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at time of screening.
3. Have ≥ 2 swollen AND ≥ 2 tender joints at randomization.
4. Consenting to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Has received study drugs (methotrexate/apremilast) in last 3 months.
2. Has received any biological DMARDs (TNFi, IL-12/23 inhibitor, IL-17 inhibitor, CTLA4-Ig) or, other small molecules (JAK inhibitors) ever.
3. Recent initiation or a change in the dose of any DMARD in last 3 months prior to randomization.
4. Oral steroid dose more than 10 mg/day of prednisolone or equivalent.
5. Renal dysfunction (serum creatinine >1.5mg/dl)
6. Liver function abnormality (SGOT and SGPT >2 times upper limit of normal and/or total bilirubin >2mg/dl)
7. Presence of anaemia (haemoglobin <9gm%), leucopenia (<3500/mm3) and thrombocytopenia (<100000/mm3)
8. Presence of comorbid illnesses like major psychiatric disorders, chronic liver disease, cardiac disease, respiratory illness and illicit substance abuse which will hamper the participation of the subject in the study.
9. Pregnant or breast-feeding females.
10. Females of child bearing potential, not willing to use contraception during study period.
11. History of allergy to any component of the study drugs.
12. Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) screening test positivity.
13. Presence of active infections, either bacterial, fungal or viral, at randomization or within the last 4 weeks prior to randomization.
14. Evidence of active tuberculosis at randomization.
15. Active malignancy.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare proportions of subjects achieving major cDAPSA response at week 24 between methotrexate and apremilast groups |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. ACR 20 at 24 weeks
2. To compare PASI score at 24 weeks
3. Enthesitis score at 24 weeks
4.To compare change in dactylitis score (Leeds dactylitis index) at week 24 between two groups.
5. HAQ DI score at 24 weeks
6. Adverse event profile
|
16 weeks and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/10/2019 |
| Date of Study Completion (India) |
31/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Samanta J, Naidu G, Chattopadhyay A, Basnet A, Narang T, Dhir V, et al. Comparison between methotrexate and apremilast in Psoriatic Arthritis-a single blind randomized controlled trial (APREMEPsA study). Rheumatol Int. 2023;43(5):841-848. doi:10.1007/s00296-023-05315-4 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Methotrexate has traditionally been the first line
choice for both cutaneous psoriasis and psoriatic arthritis with apremilast
being a new addition. Various studies showed apremilast being quite efficacious
for both “treatment modified†and “naïve†psoriatic arthritis patients.
However, there is lack of any data regarding head to head comparison between
the traditional first line agent, i.e. Methotrexate and apremilast regarding
efficacy in psoriatic arthritis patients. In view of paucity of addressing literature
regarding this pertinent issue, the current study was planned. |