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Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast 30 mg

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Apremilast, Psoriatic Arthritis, PDE4 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females, 18 years and older at time of consent.
Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
Able to adhere to the study visit schedule and other protocol requirements.
Have a documented diagnosis of psoriatic arthritis (by any criteria) of at least 3 months' duration
Meet the classification criteria for psoriatic arthritis (CASPAR) at the time of screening.
Have at least 3 swollen AND at least 3 tender joints.
Must have high sensitivity C-Reactive Protein (hs-CRP) of at least 0.5 mg/dL at screening and at baseline.
Must be receiving treatment on an outpatient basis.
Must be tumor necrosis factor (TNF) blocker naive and other Biologic naïve for dermatologic and rheumatic conditions
Subjects taking disease modifying anti-rheumatoid drugs (DMARDs), with the exception of cyclosporine and leflunomide (see 7.3. Exclusion Criteria 20, 21), do not require a washout, however, they must discontinue the DMARD treatment at least one day prior to their baseline visit (ie, Visit 2, Day 0)
Subjects who have been previously treated with leflunomide will require a 12-week washout or treatment with the cholestyramine, per leflunomide prescribing label (ie. 8 g cholestyramine 3 times daily for 11 days.
Subjects who have been previously treated with cyclosporine will require a 4-week washout prior to randomization to participate in the study
If taking oral corticosteroids, must be on a stable dose of prednisone less than or equal to 10 mg/day or equivalent for at least 30 days prior to baseline visit (ie, Day 0)
If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 30 days prior to baseline visit (ie, Day 0) and until they have completed the Week 24 study visit.
Must meet the following laboratory criteria:
- White blood cell count greater than 3000/mm^3 (greater than 3.0 X 10^9/L) and less than 14,000/mm^3 (less than 14 X 10^9/L)
- Platelet count at least 100,000/mm^3 (at least 100 X 10^9/L)
- Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to twice upper limit of normal (ULN). If initial test shows ALT or AST greater than 2 times the ULN, one repeat test is allowed during the screening period.
- Total bilirubin less than or equal to 2 mg/dL (less than or equal to 34 μmol/L) or Albumin greater than LLN. If initial test result is greater than 2 mg/dL, one repeat test is allowed during the screening period.
- Hemoglobin at least 9 g/dL (at least 5.6 mmol/L)
- Hemoglobin A1c less than or equal to 9.0%
All females of childbearing potential (FCBP) must use one of the approved contraceptive options as described below while on investigational product and for at least 28 days after administration of the last dose of the investigational product.
At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP subjects who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non latex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.

Exclusion Criteria:

History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Clinically significant abnormality on a 12-lead electrocardiogram (ECG) at Screening.
Pregnant or breast feeding.
History of allergy to any component of the investigational product.
Hepatitis B surface antigen positive at screening.
Hepatitis C antibody positive at screening.
History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
Active tuberculosis or a history of incompletely treated tuberculosis.
Clinically significant abnormality based upon chest radiograph with at least posterior-anterior (PA) view (the radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.
Active substance abuse or a history of substance abuse within 6 months prior to Screening.
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening.
Malignancy or history of malignancy, except for:
1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
2. treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
Erythrodermic, guttate, or generalized pustular psoriasis at randomization.
Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or fibromyalgia.
Functional Class IV, as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis (RA), ankylosing spondylitis, Lyme disease).
Prior treatment with more than one non-biologic DMARD
Use of the following systemic therapy(ies) within 4 weeks of randomization: cyclosporine or other calcineurin inhibitors, corticosteroids exceeding 10 mg daily prednisone equivalent, as well as other oral agents such as retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus.
Use of leflunomide within 12 weeks of randomization, unless subject has taken cholestyramine, 8g TID (three times a day) x 11 days after stopping leflunomide.
Previous treatment with biologic agents for rheumatic diseases such as, but not limited to: adalimumab, abatacept, canakinumab, etanercept, golimumab, infliximab, rilonacept, certolizumab pegol, or tocilizumab.
Previous treatment with biologic agents for dermatologic diseases such as alefacept, anti-TNFs (eg etanercept, adalinumab) or ustekinumab.
Previous treatment with tofacitinib, Anti IL-17 agents or secukinumab
Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, alemtuzumab, ocrelizumab, alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20).
Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column
Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
Prior treatment with any non-biologic DMARDS other than methotrexate, sulfasalazine, chloroquine, hydroxychloroquine, azathioprine, fumeric acid esters, cyclosporine, or leflunomide
Prior treatment with apremilast, or participation in a clinical study, involving apremilast
Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer).

Sites / Locations

Achieve Clinical Research LLC
Desert Medical Advances
Bay Area Arthritis and Osteoporosis
Health Point Medical Group
Palmetto Medical Research
Jeffrey Alper MD Research
Suncoast Clinical Research
University of South Florida
Coeur D'Alene Arthritis Clinic
Rockford Orthopedic Associates, LLC
Advanced Rheumatology
Research West Incorporated
Heartland Clinical Research, Inc.
Physicians East
Piedmont Medical Research Associates Inc
Altoona Center for Clinical Research
West Tennessee Research Institute
Ramesh C Gupta MD
Austin Regional Clinic
Baylor Research Institute
Houston Medical Research
Arthritis and Osteoporosis Associates LLP
University of Utah
Mountain State Clinical Research
Colin Bayliss Research and Teaching Unit
Eastern Health Clinical School
Royal Prince Alfred Hospital
Menzies Centre for Population Health Research
Optimus Clinical Research Pty. Ltd
Coastal Joint Care
Westmead Cancer Care Center
Manna Research
Manitoba Clinic
Karma Clinical Trials
Nexus Clinical Research
MAC Research Incorporated
Arthur Karasik Private Practice
Manna Research
Jude Rodrigues Private Practice
CHUL du CHU de Quebec
Revmatologicky ustav
Revmatologicka Ambulance
Revmatologicka Ambulance
PV - MEDICAL, s.r.o.
Innomedica Medical and Research Centre
East Tallinn Central Hospital
Clinical Research Centre Ltd
Qualiclinic kft
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
MAV Korhaz es Rendelointezet Szolnok
Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet
Waikato hospital
Middlemore Clinical Trials
Timaru Hospital
Sf. Maria Clinical Hospital
Emergency County Clinical Hospital
Sf Apostol Andrei Emergency Clinical County Hospital
SC Covamed SRL
Research Medical Complex Vashe Zdorovie
Penza Regional Clinical Hospital n.a. N.N. Burdenko
Departmental Hospital at Smolensk Station RZhD JSC
Yaroslavl Regional Clinical Hospital
Hospital Universitario a Coruna
Hospital Universitari de Bellvitge
Hospital Vall d'Hebron
Hospital de Basurto-Osakidetza
Hospital Universitario de Canarias
Hospital Universitario La Paz
Hospital General Carlos Haya
Corporacion Sanitaria Parc Tauli
Hospital Clinico Universitario de Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 30 mg

Placebo

Arm Description

30 mg Apremilast tablets administered twice daily (BID) for 24 weeks during the double-blind placebo-controlled phase; followed by 30 mg Apremilast BID for 28 weeks of active treatment phase (up to the 52 week visit); original treatment assignments remain blinded until all participants have completed their 52 week visit or have discontinued. After the Wk 52 visit, all participants in the extension phase will continue to receive treatment with apremilast 30 mg BID until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial.

Oral placebo BID during the placebo controlled phase weeks 0 to 24; placebo treated participants whose improvement is <10% in both swollen and tender joint counts at Week 16 are eligible for early escape (based on the measure of clinical benefit from their current treatment as evidenced by improvement (or lack of improvement) in 1) the physician (evaluator's) global assessment (EGA), 2) patients pain (pain NRS), 3) the patient global assessments (PGA), and 4) the health assessment questionnaire disability index (HAQ-DI); Placebo-treated patients who early escape are transitioned to apremilast 30 mg PO BID during the active treatment phase up to their Week 52 visit; all those who complete the 52-week treatment phase will enter an open-label extension phase for an additional 52 weeks or until early discontinuation from the trial.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in 78 tender joint count; ≥ 20% improvement in 76 swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24

Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; C-reactive protein (CRP) Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A higher value indicates higher disease activity, and a negative change from baseline indicates improvement.

Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.

Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24

The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score includes the physical functioning, role physical, bodily pain, and general health domains. Minimum clinically important difference (MCID) for the scale scores, as well as the PCS and MCS, is defined as a 2.5-point improvement (increase) from baseline. The summary scores range from 0 to 100, with lower scores reflecting more disability, and higher scores reflecting less disability and better health. The 8 domains are regrouped into the PCS and MCS scores.

Change From Baseline in the Duration of Morning Stiffness at Week 24

Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.

Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24

Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. The response of no improvement includes subjects who had no change or worsened. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16

Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; C-reactive protein (CRP) Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.

Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16

The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Mean Change From Baseline in the Duration of Morning Stiffness at Week 16

Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline

Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104

Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; C-reactive protein (CRP) Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.

Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104

The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104

Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase

A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period

Full Information

NCT ID

NCT01925768

First Posted

August 15, 2013

Last Updated

April 28, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01925768

Brief Title

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Official Title

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) Monotherapy in Subjects With Active Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 4, 2013 (Actual)

Primary Completion Date

February 25, 2015 (Actual)

Study Completion Date

November 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

Detailed Description

This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast monotherapy in subjects with active psoriatic arthritis. Approximately 214 subjects will be randomized in a 1:1 ratio to either apremilast 30 mg BID (twice a day) or identically-appearing placebo, with approximately 107 subjects per treatment group. This is a 113-week study. The subjects will spend 24 weeks in the double-blind, placebo-controlled treatment phase, followed by 28 weeks of active treatment phase (ie, up to Week 52 visit). The original treatment assignments (apremilast 30 mg BID (twice a day) or placebo) will remain blinded until all subjects have completed their Week 52 visit (or have discontinued). After the Week 52 visit, all subjects in the extension phase will continue to receive treatment with apremilast 30 mg BID (twice a day) until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial. The study will consist of 5 phases: Screening Phase - up to 5 weeks Randomized, Placebo-controlled, Double Blind Treatment Phase - Weeks 0 to 24 Active Treatment Phase - Week 24 to Week 52 Open-label Extension Phase - Week 52 to Week 104 Post-treatment Observational Follow-up Phase

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Apremilast, Psoriatic Arthritis, PDE4 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 30 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apremilast 30 mg

Other Intervention Name(s)

Otezla, CC-10004

Intervention Description

30mg of Apremilast will be orally administered twice daily for 104 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16

Description

Time Frame

Baseline and Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Duration of Morning Stiffness at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16

Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; C-reactive protein (CRP) Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.

Time Frame

Baseline and Week 16

Title

Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16

Description

The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Time Frame

Baseline and Week 16

Title

Mean Change From Baseline in the Duration of Morning Stiffness at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline

Description

Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Time Frame

Baseline and Week 16

Title

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20

Description

Time Frame

Baseline and at Weeks 2, 4, 6, 8, 12 and 20

Title

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104

Description

Time Frame

Baseline and Weeks 52 and 104

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104

Description

Time Frame

Baseline and Weeks 52 and 104

Title

Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104

Description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: 28 tender joint count 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; C-reactive protein (CRP) Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.

Time Frame

Baseline and Weeks 52 and 104

Title

Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104

Description

The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Time Frame

Baseline and Weeks 52 and 104

Title

Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104

Description

Time Frame

Baseline and Weeks 52 and 104

Title

Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline

Description

Time Frame

Baseline and Weeks 52 and 104

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase

Description

Time Frame

Date of first dose of study drug to Week 24; median duration of exposure during placebo controlled phase was 24.14 weeks

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period

Description

Time Frame

Start of lst dose of IP up to week 104: Weeks 0 to104 for those initially randomized to APR 30 mg BID, Weeks 16 -104 for PBO-treated patients who EE to APR at Week 16 and from Weeks 24-104 for PBO-treated patients who transitioned to APR at Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females, 18 years and older at time of consent. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. Able to adhere to the study visit schedule and other protocol requirements. Have a documented diagnosis of psoriatic arthritis (by any criteria) of at least 3 months' duration Meet the classification criteria for psoriatic arthritis (CASPAR) at the time of screening. Have at least 3 swollen AND at least 3 tender joints. Must have high sensitivity C-Reactive Protein (hs-CRP) of at least 0.5 mg/dL at screening and at baseline. Must be receiving treatment on an outpatient basis. Must be tumor necrosis factor (TNF) blocker naive and other Biologic naïve for dermatologic and rheumatic conditions Subjects taking disease modifying anti-rheumatoid drugs (DMARDs), with the exception of cyclosporine and leflunomide (see 7.3. Exclusion Criteria 20, 21), do not require a washout, however, they must discontinue the DMARD treatment at least one day prior to their baseline visit (ie, Visit 2, Day 0) Subjects who have been previously treated with leflunomide will require a 12-week washout or treatment with the cholestyramine, per leflunomide prescribing label (ie. 8 g cholestyramine 3 times daily for 11 days. Subjects who have been previously treated with cyclosporine will require a 4-week washout prior to randomization to participate in the study If taking oral corticosteroids, must be on a stable dose of prednisone less than or equal to 10 mg/day or equivalent for at least 30 days prior to baseline visit (ie, Day 0) If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 30 days prior to baseline visit (ie, Day 0) and until they have completed the Week 24 study visit. Must meet the following laboratory criteria: White blood cell count greater than 3000/mm^3 (greater than 3.0 X 10^9/L) and less than 14,000/mm^3 (less than 14 X 10^9/L) Platelet count at least 100,000/mm^3 (at least 100 X 10^9/L) Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to twice upper limit of normal (ULN). If initial test shows ALT or AST greater than 2 times the ULN, one repeat test is allowed during the screening period. Total bilirubin less than or equal to 2 mg/dL (less than or equal to 34 μmol/L) or Albumin greater than LLN. If initial test result is greater than 2 mg/dL, one repeat test is allowed during the screening period. Hemoglobin at least 9 g/dL (at least 5.6 mmol/L) Hemoglobin A1c less than or equal to 9.0% All females of childbearing potential (FCBP) must use one of the approved contraceptive options as described below while on investigational product and for at least 28 days after administration of the last dose of the investigational product. At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP subjects who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non latex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product. Exclusion Criteria: History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. Clinically significant abnormality on a 12-lead electrocardiogram (ECG) at Screening. Pregnant or breast feeding. History of allergy to any component of the investigational product. Hepatitis B surface antigen positive at screening. Hepatitis C antibody positive at screening. History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease). Active tuberculosis or a history of incompletely treated tuberculosis. Clinically significant abnormality based upon chest radiograph with at least posterior-anterior (PA) view (the radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required. Active substance abuse or a history of substance abuse within 6 months prior to Screening. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening. Malignancy or history of malignancy, except for: treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization. Erythrodermic, guttate, or generalized pustular psoriasis at randomization. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or fibromyalgia. Functional Class IV, as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis (RA), ankylosing spondylitis, Lyme disease). Prior treatment with more than one non-biologic DMARD Use of the following systemic therapy(ies) within 4 weeks of randomization: cyclosporine or other calcineurin inhibitors, corticosteroids exceeding 10 mg daily prednisone equivalent, as well as other oral agents such as retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus. Use of leflunomide within 12 weeks of randomization, unless subject has taken cholestyramine, 8g TID (three times a day) x 11 days after stopping leflunomide. Previous treatment with biologic agents for rheumatic diseases such as, but not limited to: adalimumab, abatacept, canakinumab, etanercept, golimumab, infliximab, rilonacept, certolizumab pegol, or tocilizumab. Previous treatment with biologic agents for dermatologic diseases such as alefacept, anti-TNFs (eg etanercept, adalinumab) or ustekinumab. Previous treatment with tofacitinib, Anti IL-17 agents or secukinumab Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, alemtuzumab, ocrelizumab, alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20). Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation. Prior treatment with any non-biologic DMARDS other than methotrexate, sulfasalazine, chloroquine, hydroxychloroquine, azathioprine, fumeric acid esters, cyclosporine, or leflunomide Prior treatment with apremilast, or participation in a clinical study, involving apremilast Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Achieve Clinical Research LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Bay Area Arthritis and Osteoporosis

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Health Point Medical Group

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Palmetto Medical Research

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Jeffrey Alper MD Research

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Suncoast Clinical Research

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-4799

Country

United States

Facility Name

Coeur D'Alene Arthritis Clinic

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Rockford Orthopedic Associates, LLC

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

Advanced Rheumatology

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research West Incorporated

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Heartland Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Physicians East

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Piedmont Medical Research Associates Inc

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103-3914

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

West Tennessee Research Institute

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Ramesh C Gupta MD

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Baylor Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Houston Medical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Arthritis and Osteoporosis Associates LLP

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Mountain State Clinical Research

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Colin Bayliss Research and Teaching Unit

City

Victoria Park

State/Province

Western Australia

ZIP/Postal Code

6100

Country

Australia

Facility Name

Eastern Health Clinical School

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Royal Prince Alfred Hospital

City

Camperdown

ZIP/Postal Code

2050

Country

Australia

Facility Name

Menzies Centre for Population Health Research

City

Hobart,

ZIP/Postal Code

7000

Country

Australia

Facility Name

Optimus Clinical Research Pty. Ltd

City

Kogarah

ZIP/Postal Code

2217

Country

Australia

Facility Name

Coastal Joint Care

City

Maroochydore

ZIP/Postal Code

4558

Country

Australia

Facility Name

Westmead Cancer Care Center

City

Westmead, NSW

ZIP/Postal Code

2145

Country

Australia

Facility Name

Manna Research

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6J 1S3

Country

Canada

Facility Name

Manitoba Clinic

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A1M3

Country

Canada

Facility Name

Karma Clinical Trials

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 4Y3

Country

Canada

Facility Name

Nexus Clinical Research

City

St John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 5E8

Country

Canada

Facility Name

MAC Research Incorporated

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

Arthur Karasik Private Practice

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9C 5N2

Country

Canada

Facility Name

Manna Research

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W4L6

Country

Canada

Facility Name

Jude Rodrigues Private Practice

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

CHUL du CHU de Quebec

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Revmatologicka Ambulance

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Revmatologicka Ambulance

City

Sokolov

ZIP/Postal Code

356 01

Country

Czechia

Facility Name

PV - MEDICAL, s.r.o.

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Innomedica Medical and Research Centre

City

Tallinn

ZIP/Postal Code

EE-10117

Country

Estonia

Facility Name

East Tallinn Central Hospital

City

Tallinn

ZIP/Postal Code

EE-11412

Country

Estonia

Facility Name

Clinical Research Centre Ltd

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

Qualiclinic kft

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

MAV Korhaz es Rendelointezet Szolnok

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Waikato hospital

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

Middlemore Clinical Trials

City

Manukau

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

Timaru Hospital

City

Timaru

ZIP/Postal Code

8601

Country

New Zealand

Facility Name

Sf. Maria Clinical Hospital

City

Bucharest

ZIP/Postal Code

011172

Country

Romania

Facility Name

Emergency County Clinical Hospital

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Sf Apostol Andrei Emergency Clinical County Hospital

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

SC Covamed SRL

City

Sfantu Gheorghe, Covasna

ZIP/Postal Code

520052

Country

Romania

Facility Name

Research Medical Complex Vashe Zdorovie

City

Kazan

ZIP/Postal Code

420103

Country

Russian Federation

Facility Name

Penza Regional Clinical Hospital n.a. N.N. Burdenko

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Departmental Hospital at Smolensk Station RZhD JSC

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Yaroslavl Regional Clinical Hospital

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Hospital Universitario a Coruna

City

A Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitari de Bellvitge

City

Barcelona, Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital de Basurto-Osakidetza

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital Universitario de Canarias

City

La Laguna

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital General Carlos Haya

City

Málaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Corporacion Sanitaria Parc Tauli

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Clinico Universitario de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

29343507

Citation

Nash P, Ohson K, Walsh J, Delev N, Nguyen D, Teng L, Gomez-Reino JJ, Aelion JA; ACTIVE investigators. Early and sustained efficacy with apremilast monotherapy in biological-naive patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018 May;77(5):690-698. doi: 10.1136/annrheumdis-2017-211568. Epub 2018 Jan 17.

Results Reference

background

Learn more about this trial

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

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