A study to evaluate safety and effectiveness of Apremilast drug in patients suffering from a disease of stiff and swollen joints (arthritis) along with disease of skin (psoriasis)

Phase 4

Active, not recruiting

• Conditions: Health Condition 1: L405- Arthropathic psoriasis

• Registration Number: CTRI/2019/01/017122
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients who meet ALL the following criteria can be enrolled:

1.Males or females, aged � 18 years and � 65 years at time of informed consent.

2.Subjects having a diagnosis of Psoriatic Arthritis (PsA, by any criteria) for � 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 � 3 swollen AND � 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 � 10 mg or equivalent) allowed.

9.Must have psoriasis of body surface area (BSA: �3%).

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

Study & Design

• Study Type: PMS
• Study Design: Not specified