APREMEPSa study: A comparative study between Apremilast and Methotrexate regarding their efficacy in psoriatic arthritis
- Conditions
- Health Condition 1: M07- Enteropathic arthropathies
- Registration Number
- CTRI/2019/10/021723
- Lead Sponsor
- o sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare proportions of subjects achieving major cDAPSA response at week 24 between methotrexate and apremilast groupsTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method 1. ACR 20 at 24 weeks <br/ ><br>2. To compare PASI score at 24 weeks <br/ ><br>3. Enthesitis score at 24 weeks <br/ ><br>4.To compare change in dactylitis score (Leeds dactylitis index) at week 24 between two groups. <br/ ><br>5. HAQ DI score at 24 weeks <br/ ><br>6. Adverse event profile <br/ ><br>Timepoint: 16 weeks and 24 weeks