Health Condition 1: L405- Arthropathic psoriasis
Conditions
Interventions
Intervention1: Apremilast tablets: Day 1: Apremilast Tablet 10 mg in morning
Day 2: Apremilast Tablet 10 mg in morning and 10 mg in evening
Day 3: Apremilast Tablet 10 mg in morning and 20 mg in eveni
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet ALL the following criteria can be enrolled: 1.Males or females, aged â�¥ 18 years and â�¤ 65 years at time of informed consent. 2.Subjects having a diagnosis of Psoriatic Arthritis (PsA, by any criteria) for â�¥ 6 months duration. 3.Subjects meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at time of screening. 4.May not have axial involvement alone 5.Treatment na�¯ve patients or patients taking concurrent DMARDs at baseline could continue stable doses of methotrexate (â�¤ 25 mg/week), leflunomide (â�¤ 20 mg/day), sulfasalazine (â�¤ 2 g/day) 6.Must have â�¥ 3 swollen AND â�¥ 3 tender joints. 7.Female subjects of child bearing potential must use medically accepted form of contraception 8.Patients on stable dose of NSAIDs, narcotics and low dose oral corticosteroids (prednisone â�¤ 10 mg or equivalent) allowed. 9.Must have psoriasis of body surface area (BSA: â�¥3%).
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients who meet AT LEAST one of the following exclusion criteria will be excluded: 1.Pregnant or lactating women or planning to become pregnant during the study period. 2.History of allergy to any component of the investigational product 3.Subjects with known positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency, hepatitis B or C 4.Therapeutic failure on > 3 agents for PsA or > 1 biologic tumour necrosis factor (TNF) blocker, IL-17 inhibitors discontinued within 3 months of screening. 5.History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations 6.Subjects with uncontrolled hypertension or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension 7.Subjects with a history or known diagnosis of uncontrolled diabetes mellitus or requiring insulin treatment 8.Subjects with recent history or who are currently known to abuse alcohol or drugs 9.Subjects who have participated in another clinical study within past one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) during the course of the study 2. Number of subjects who prematurely discontinue IP due to adverse events 3. Changes in Vital Signs and Body weight from Baseline to End of Study. 4. Changes in Laboratory Safety Parameters (Haematology, Serum Biochemistry) from Baseline to End of Study.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at Week 16 and Week 24 2. Change in Health Assessment Questionnaire Disability Index (HAQDI) at Week 24 3. Change in Leeds Enthesitis Index (LEI) at Week 16 and Week 24 4. Change From Baseline in Dactylitis Severity Score at Week 16 and Week 24 5. Percentage of Participants Achieving ââ?°Â¥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16 and Week 24Timepoint: Week 16 and Week 24 | — |
Countries
India
Contacts
Public ContactDr Dhiraj Dhoot
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed