Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.

Phase 4

Completed

Conditions: Arthritis, Psoriatic

Interventions: Drug: Apremilast (CC-10004)
Other: Apremilast (CC-10004) Placebo

Registration Number: NCT03747939

Lead Sponsor: Amgen

Brief Summary: This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 310

Inclusion Criteria

≥ 18 yrs, male or female subject
Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
SJC AND TJC must be >1 and ≤ 4
For all regions, the local Regulatory Label for treatment with apremilast must be followed.
Stable doses of protocol-allowed PsA medications
General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
Comply with protocol-required contraception measures
Subject meets the Classification Criteria for Psoriatic Arthritis [CASPAR] Criteria for PsA at the Screening visit

Exclusion Criteria

Prior use of >2 csDMARD to treat PsA
Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
Prior use of cyclosporine.
Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD	Apremilast (CC-10004)	Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Placebo	Apremilast (CC-10004) Placebo	Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16	Week 16	MDA is defined as tender joint counts (TJC) ≤ 1 and SJC ≤ 1 plus 3 of the following 5 criteria: 1. psoriasis body surface area (BSA) ≤ 3% 2. patient's pain visual analogue scale (VAS) on a 100 mm scale ≤ 15; where 0 indicates 'no pain' and 100 indicates 'pain as severe as can be imagined' 3. patient's global assessment of disease activity on a 100 mm scale ≤ 20, where 0 represents the lowest level of disease activity and 100 represents the highest. 4. physical function assessed by Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5; where 0 represents normal or no difficulty and 3 represents an inability to perform 5. enthesitis count ≤ 1 based on the Leeds Enthesitis Index; where 0 means nontender and 6 indicates 6 tender tendon insertions.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16	Baseline and Week 16	The PsAID-12 Questionnaire is a 12-item, self-administered questionnaire that reflects the impact of psoriatic arthritis from the perspective of the participant. The overall score ranges from 0 (best status) to 10 (worst status), with a cut-off ≤ 4 representing patient-acceptable symptom state. Analysis was based on a mixed-effects model for repeated measures (MMRM), which included treatment group, time, treatment group by time interaction, prior/concomitant use of csDMARD (naive, prior use only, both prior and concomitant use) and baseline glucocorticosteroid use (yes/no) per IWRS data as factors, and baseline value as a covariate.
Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16	Baseline and Week 16	The PASDAS is a weighted index comprising assessments of joints, function, acute-phase response, quality of life, and patient and physician VAS. The score range of the PASDAS is 0 - 10, with worse disease activity represented by higher scores. A good response is defined as a PASDAS score of ≤ 3.2 with improvement from baseline ≥ 1.6 points. A moderate response is defined as a PASDAS score \> 3.2 with improvement from baseline ≥ 1.6 points; or PASDAS score \< 5.4 with improvement from baseline ≥ 0.8 but \< 1.6 points.
Percentage of Participants With TJC ≤ 1 at Week 16	Week 16	The TJC was based on 68 joints and at week 16 was based on the sentinel joints (i.e., the joints that were affected at baseline). A TJC response is defined as a count ≤ 1.
Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16	Week 16	The Patient's Global Assessments of Disease Activity is an assessment of how active a participant's psoriatic arthritis was on average during the last week. It was assessed on a VAS ranging from 0 to 100 mm, with a higher score indicating more disease activity. A response is defined as a score ≤ 20 mm.
Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16	Week 16	The Patients Pain VAS is the participant's assessment of how much pain they had, on average, during the last week in their joints due to psoriatic arthritis. The VAS score ranges from 0 to 100 mm, with a higher score indicating more pain.
Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA)	Week 16	The cDAPSA score is based on the numerical summation of 4 disease activity variables: tender and swollen joints, patient's global assessments of disease activity and assessment of pain (VAS). The cDAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. cDAPSA remission is defined as a DAPSA score ≤ 4 and low disease activity is defined as a cDAPSA score \> 4 but ≤ 13).
Percentage of Participants With SJC ≤ 1 at Week 16	Week 16	The SJC was based on 66 joints and at week 16 is based on the sentinel joints (i.e., the joints that were affected at baseline). A SJC response is defined as a count ≤ 1.

Trial Locations

Locations (113): West Tennessee Research Institute, llc
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Jackson, Tennessee, United States
Dr Sabeen Anwar Medicine Professional Corporation
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Windsor, Ontario, Canada
Charite - Universitaetsmedizin Berlin, Campus Mitte
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Berlin, Germany
Research Institute of Rheumatology named after V A Nasonova
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Moscow, Russian Federation
Moscow Regional Research Institute n a Vladimirsky
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Moscow, Russian Federation
Arizona Arthritis and Rheumatology Research, PLLC
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Mesa, Arizona, United States
Covina Arthritis Clinic
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Covina, California, United States
Encino Research Center
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Encino, California, United States
Providence Medical Foundation
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Fullerton, California, United States
Rheumatology Center of San Diego PC
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San Diego, California, United States
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West Tennessee Research Institute, llc
🇺🇸Jackson, Tennessee, United States