Back to results

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Apremilast

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, ACR, PASI, DAS, pharmacokinetic, biopsy

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
Active psoriatic arthritis at the time of screening and baseline as defined by: 3 or more swollen joints AND 3 or more tender joints
Negative rheumatoid factor (RF)
If using methotrexate, be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study
If using oral corticosteroids, be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study
If using nonsteroidal anti-inflammatory drug (NSAID) therapy, be on a stable dose for at least 14 days prior to screening and throughout the study
Must meet the following laboratory criteria:
- Hemoglobin ≥ 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000/μL (≥ 3.0 X 10^9/L) and < 20,000/μL (< 20 X 10^9/L)
- Neutrophils ≥ 1500 /μL (≥ 1.5 X 10^9/L)
- Platelets ≥ 100,000 /μL (≥ 100 X 10^9/L)
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- Total bilirubin ≤ 2.0 mg/dL
- Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ≤ 1.5x upper limit of normal (ULN)
Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO adequate forms of contraception while on study medication. A FCBP must agree to have pregnancy tests every 28 days while on study medication
Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for at least 84 days after taking the last dose of study medication

Exclusion Criteria:

History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases

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
Pregnant or lactating female
History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated.
History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T SPOT®.TB, QuantiFERON Gold®])
Clinically significant abnormality on the chest x-ray (CXR) at screening
Current erythrodermic, guttate, or pustular forms of psoriasis
History of infected joint prosthesis within the past 5 years
Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, ≤ 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study
Topical therapy for the treatment of psoriasis including, but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer's suggested usage. Nonmedicated emollients [eg, Eucerin®] and tar shampoo are also allowed.)
Phototherapy (ultraviolet light A [UVA], narrow-band ultraviolet light B [NB-UVB], psoralens and long-wave ultraviolet radiation [PUVA]) within 28 days prior to randomization
Etanercept use within 56 days prior to randomization
Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization
Alefacept use within 168 days (24 weeks) prior to randomization
Use of intra-articular corticosteroids within 28 days prior to randomization
Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)
Any clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection
History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)
Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis

Sites / Locations

CHU Brugmann
Universiteit Hasselt
University Hospital
Jan Palfijn Ziekenhuis
The Arthritis Research Centre of Canada
Nexus Clinical Research
Burlington Rheumatology and Osteoporosis Clinic
MAC Research Inc.
K-W Musculoskeletal Research Inc.
Credit Valley Rheumatology
Arthritis Program Research Group Inc
Rheumatology Research Associates
Center for Prognosis Studies in the Rheumatic Diseases University Health Network, Toronto Western Hospital
Mount Sinai Hospital
Probity Medical
Clinical Research and Arthritis Centre
West Island Rheumatology Research Associates
Saskatoon Osteoporosis Center
Capio Franz von Prümmer Klinik
Free University of Berlin
Universitaetsklinikum Frankfurt
Klinikum Eilbek
Universitaet Heidelberg
Rheumazentrum Ruhrgebiet
Universitaetsklinik Koeln
Universitaet Leipzig
Universitaetsklinikum Leipzig
University of Munich
Klinikum der Universität Munster
Friedrich-Alexander University, Erlangen
Hagaziekenhuis
Leiden University Medical Centre
Radboud University
Hope Hospital
Haywood Hospital
Chapel Allerton Hospital
Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 40 mg QD

Apremilast 20 mg BID

Placebo

Arm Description

Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.

Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.

Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12

A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Secondary Outcome Measures

Number of Participants With Adverse Events During the Treatment Phase

The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12

A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.

Percentage of Participants With a Modified ACR 50 Response at Week 12

A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Percentage of Participants With a Modified ACR 70 Response at Week 12

A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = [0.56*√(TJC28) + 0.28*√(SJC28) + 0.36*ln(CRP+1)] * 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12

The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6.

Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12

The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.

Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy

The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.

Number of Participants With Adverse Events Leading to a Dose Reduction

The number of participants who were dose reduced during the treatment phase due to adverse events.

Maximal ACR Response During the Treatment Phase

The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved.

Time to ACR 20 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.

Time to ACR 50 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.

Time to ACR 70 Response During the Treatment Phase

The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.

Change From Baseline in Dactylitis Severity Score at Week 12

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.

Percentage of Participants With Enthesitis

Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.

Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.

Number of Participants Who Relapsed During the Observational Follow-up Phase

Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12

The Medical Outcome SF 36-Item Health Survey, Version 2 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 summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.

Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12

The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.

Number of Participants With Adverse Events During the Extension Phase

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24

A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.

Percentage of Participants With a Modified ACR 20 Response at Week 24

A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.

Percentage of Participants With a Modified ACR 50 Response at Week 24

A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.

Percentage of Participants With a Modified ACR 70 Response at Week 24

A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal [CMC] and the distal interphalangeal [DIP] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders.

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24

The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56*√(TJC28) + 0.28*(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 > 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 > 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 > 1.2 and a DAS28 score > 3.2

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24

Maximal ACR Response During the Extension Period

The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved.

Time to ACR 20 Response During the Study

Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.

Time to ACR 50 Response During the Treatment and Extension Phase

Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.

Time to ACR 70 Response During the Treatment and Extension Phase

Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.

Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24

Percentage of Participants With Enthesitis in the Extension Phase

Time to Relapse of Psoriatic Arthritis After Extension Phase

Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.

Number of Participants Who Relapsed After the Extension Phase

Change From Baseline and Week 12 in SF-36 at Week 24

Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24

The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.

Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24

Full Information

NCT ID

NCT00456092

First Posted

April 2, 2007

Last Updated

June 18, 2020

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00456092

Brief Title

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

Official Title

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Dose Regimens of CC-10004 in Subjects With Active Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

March 5, 2007 (Actual)

Primary Completion Date

May 9, 2009 (Actual)

Study Completion Date

May 9, 2009 (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

This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.

Detailed Description

Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days treatment in the placebo controlled treatment phase, up to 84 days treatment in the active treatment extension phase and a 28 day follow up. Participants who completed the treatment phase prior to implementation of amendment 1/UK3 did not have the option of entering the extension phase.

6. Conditions and Keywords

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

Psoriatic Arthritis

Keywords

psoriatic arthritis, ACR, PASI, DAS, pharmacokinetic, biopsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 40 mg QD

Arm Type

Experimental

Arm Description

Arm Title

Apremilast 20 mg BID

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

CC-10004, Otezla®

Intervention Description

Capsules for oral administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules for oral administration

Primary Outcome Measure Information:

Title

Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events During the Treatment Phase

Description

Time Frame

12 weeks

Title

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With a Modified ACR 50 Response at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With a Modified ACR 70 Response at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12

Description

Time Frame

Week 12

Title

Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy

Description

Time Frame

Baseline to Week 12

Title

Number of Participants With Adverse Events Leading to a Dose Reduction

Description

The number of participants who were dose reduced during the treatment phase due to adverse events.

Time Frame

Baseline to Week 12

Title

Maximal ACR Response During the Treatment Phase

Description

Time Frame

ACR was measured at Baseline and Weeks 2, 4, 6, 8, 10, and 12

Title

Time to ACR 20 Response During the Treatment Phase

Description

The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.

Time Frame

Baseline to Week 12

Title

Time to ACR 50 Response During the Treatment Phase

Description

The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.

Time Frame

Baseline to Week 12

Title

Time to ACR 70 Response During the Treatment Phase

Description

The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.

Time Frame

Baseline to Week 12

Title

Change From Baseline in Dactylitis Severity Score at Week 12

Description

Time Frame

Baseline and Week 12

Title

Percentage of Participants With Enthesitis

Description

Time Frame

Baseline and Week 12

Title

Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase

Description

Time Frame

From Week 12 to end of 28-day observational follow-up (1) and from the date of maximal ACR during the 12-week Treatment Phase until the end of the 28-day observational follow-up phase (2).

Title

Number of Participants Who Relapsed During the Observational Follow-up Phase

Description

Time Frame

28-day observational follow-up period following Week 12

Title

Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12

Description

Time Frame

Baseline and Week 12

Title

Number of Participants With Adverse Events During the Extension Phase

Description

Time Frame

Weeks 12 to 24 (Extension Phase)

Title

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24

Description

A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.

Time Frame

Baseline and Week 24

Title

Percentage of Participants With a Modified ACR 20 Response at Week 24

Description

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

Title

Percentage of Participants With a Modified ACR 50 Response at Week 24

Description

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

Title

Percentage of Participants With a Modified ACR 70 Response at Week 24

Description

Time Frame

Baseline (Day 1) and Week 24

Title

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Maximal ACR Response During the Extension Period

Description

Time Frame

ACR was measured at Baseline and Weeks 16, 20 and 24

Title

Time to ACR 20 Response During the Study

Description

Time Frame

Baseline to Week 24

Title

Time to ACR 50 Response During the Treatment and Extension Phase

Description

Time Frame

Baseline to Week 24

Title

Time to ACR 70 Response During the Treatment and Extension Phase

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24

Description

Time Frame

Baseline, Week 12 and Week 24

Title

Percentage of Participants With Enthesitis in the Extension Phase

Description

Time Frame

Week 12 and Week 24

Title

Time to Relapse of Psoriatic Arthritis After Extension Phase

Description

Time Frame

From Week 24 to the end of the 28-day follow-up (1) and from the date of maximal ACR until the end of the 28-day follow-up phase (2).

Title

Number of Participants Who Relapsed After the Extension Phase

Description

Time Frame

Week 24 to Week 28 (28-day follow-up period)

Title

Change From Baseline and Week 12 in SF-36 at Week 24

Description

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

Title

Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24

Description

The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

Title

Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

Description

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

Title

Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24

Description

Time Frame

Baseline (Day 1), Week 12 (Day 85) and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months Active psoriatic arthritis at the time of screening and baseline as defined by: 3 or more swollen joints AND 3 or more tender joints Negative rheumatoid factor (RF) If using methotrexate, be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study If using oral corticosteroids, be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study If using nonsteroidal anti-inflammatory drug (NSAID) therapy, be on a stable dose for at least 14 days prior to screening and throughout the study Must meet the following laboratory criteria: Hemoglobin ≥ 9 g/dL Hematocrit ≥ 27% White blood cell (WBC) count ≥ 3000/μL (≥ 3.0 X 10^9/L) and < 20,000/μL (< 20 X 10^9/L) Neutrophils ≥ 1500 /μL (≥ 1.5 X 10^9/L) Platelets ≥ 100,000 /μL (≥ 100 X 10^9/L) Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L) Total bilirubin ≤ 2.0 mg/dL Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ≤ 1.5x upper limit of normal (ULN) Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO adequate forms of contraception while on study medication. A FCBP must agree to have pregnancy tests every 28 days while on study medication Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for at least 84 days after taking the last dose of study medication Exclusion Criteria: History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases 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 Pregnant or lactating female History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated. History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T SPOT®.TB, QuantiFERON Gold®]) Clinically significant abnormality on the chest x-ray (CXR) at screening Current erythrodermic, guttate, or pustular forms of psoriasis History of infected joint prosthesis within the past 5 years Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, ≤ 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study Topical therapy for the treatment of psoriasis including, but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer's suggested usage. Nonmedicated emollients [eg, Eucerin®] and tar shampoo are also allowed.) Phototherapy (ultraviolet light A [UVA], narrow-band ultraviolet light B [NB-UVB], psoralens and long-wave ultraviolet radiation [PUVA]) within 28 days prior to randomization Etanercept use within 56 days prior to randomization Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization Alefacept use within 168 days (24 weeks) prior to randomization Use of intra-articular corticosteroids within 28 days prior to randomization Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer) Any clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas) Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

CHU Brugmann

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Universiteit Hasselt

City

Diepenbeek

ZIP/Postal Code

3590

Country

Belgium

Facility Name

University Hospital

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Jan Palfijn Ziekenhuis

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

The Arthritis Research Centre of Canada

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1L7

Country

Canada

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8P4Y3

Country

Canada

Facility Name

Nexus Clinical Research

City

St Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3E1

Country

Canada

Facility Name

Burlington Rheumatology and Osteoporosis Clinic

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7R 4B7

Country

Canada

Facility Name

MAC Research Inc.

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 2B6

Country

Canada

Facility Name

K-W Musculoskeletal Research Inc.

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Credit Valley Rheumatology

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

Arthritis Program Research Group Inc

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Rheumatology Research Associates

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 1A2

Country

Canada

Facility Name

Center for Prognosis Studies in the Rheumatic Diseases University Health Network, Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Mount Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3L9

Country

Canada

Facility Name

Probity Medical

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J1C4

Country

Canada

Facility Name

Clinical Research and Arthritis Centre

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

West Island Rheumatology Research Associates

City

Pointe-Claire

State/Province

Quebec

Country

Canada

Facility Name

Saskatoon Osteoporosis Center

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Capio Franz von Prümmer Klinik

City

Bad Brückenau

ZIP/Postal Code

97769

Country

Germany

Facility Name

Free University of Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Universitaetsklinikum Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Klinikum Eilbek

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Universitaet Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet

City

Herne

ZIP/Postal Code

44652

Country

Germany

Facility Name

Universitaetsklinik Koeln

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Universitaet Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitaetsklinikum Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

University of Munich

City

Munich

ZIP/Postal Code

80336

Country

Germany

Facility Name

Klinikum der Universität Munster

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Friedrich-Alexander University, Erlangen

City

Nuremberg

ZIP/Postal Code

91054

Country

Germany

Facility Name

Hagaziekenhuis

City

Den Haag

ZIP/Postal Code

2454 CH

Country

Netherlands

Facility Name

Leiden University Medical Centre

City

Leiden

ZIP/Postal Code

2300

Country

Netherlands

Facility Name

Radboud University

City

Nijmegen

ZIP/Postal Code

6500

Country

Netherlands

Facility Name

Hope Hospital

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Haywood Hospital

City

Stoke on Trent

State/Province

Staffs

ZIP/Postal Code

ST6 7AG

Country

United Kingdom

Facility Name

Chapel Allerton Hospital

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Freeman Hospital

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

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

22806399

Citation

Schett G, Wollenhaupt J, Papp K, Joos R, Rodrigues JF, Vessey AR, Hu C, Stevens R, de Vlam KL. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 Oct;64(10):3156-67. doi: 10.1002/art.34627.

Results Reference

background

PubMed Identifier

23588944

Citation

Strand V, Schett G, Hu C, Stevens RM. Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study. J Rheumatol. 2013 Jul;40(7):1158-65. doi: 10.3899/jrheum.121200. Epub 2013 Apr 15.

Results Reference

result

Learn more about this trial

Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis

We'll reach out to this number within 24 hrs