Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis (POSTURE)

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondyloarthritis
• Intervention / Treatment: Drug: Apremilast tablet 20 mg; Drug: Apremilast tablet 30 mg BID; Drug: Placebo

Detailed Description

Patients were randomized in a 1:1:1 ratio to placebo, apremilast 20 mg BID and apremilast 30 mg BID. The duration of the study was approximately 5 years. The double blind period (when patients nor the physician knew whether placebo or apremilast was taken) was 24 weeks. At Week 16, participants who did not have either a ≥ 20% improvement or a ≥ 1 unit improvement from baseline in at least two of the four SpondyloArthritis international Society (ASAS) domains were entered in "early escape" from their current treatment in a double-blinded manner. However, such participants were permitted to continue in the study. At Week 24, participants may have entered a long-term extension phase for up to an additional 4.5 years (236 weeks). At "second escape" (at Week 24), apremilast 20 mg BID treated participants transitioned to receive double-blinded apremilast 30 mg BID and remained on double-blinded apremilast 30 mg BID because they continued to improve with a longer duration of treatment. After Week 24 and during the early portion of the long-term extension through Week 52, all participants continued on either double-blinded apremilast 20 mg BID or 30 mg BID treatment. After all participants had completed Week 52 or had terminated early from the study and the 52-week data base was locked, apremilast 20 mg BID or 30 mg BID treatment was provided.

• Study Type: Interventional
• Enrollment (Actual): 490
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Maroochydore, Australia, 4558
    • Coastal Joint Care
  • Perth, Australia, 6849
    • Royal Perth Hospital
  • Woodville South, Australia, 5011
    • The Queen Elizabeth Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Southern Clinical Research
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
• Austria
  • Wien, Austria, 1130
    • Krankenhaus Wien-Hietzing
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Diagnostic and Consulting Center Sv. Pantaleymon
  • Sofia, Bulgaria, 1233
    • National Multiprofile Transport Hospital Tzar Boris III
  • Sofia, Bulgaria, 1505
    • 17 Diagnostic and Consulting Centre
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - MHAT
  • Varna, Bulgaria, 9010
    • Diagnostic Consulting Center N4
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1A 5EB
      • Nexus Clinical Research
  • Ontario
    • Hamilton, Ontario, Canada, L8N 2B6
      • Cividino Medicine Professional Corporation
    • Hamilton, Ontario, Canada, L8N1Y2
      • Dr. William G. Bensen Medicine Professional Corporation
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Professional Building
    • Newmarket, Ontario, Canada, L3Y 3R7
      • The Arthritis Program Research Group Inc.
    • Ottawa, Ontario, Canada, K1H1A2
      • Rheumatology Research Associates
    • Toronto, Ontario, Canada, M5T 258
      • Toronto Western Hospital
  • Quebec
    • Saint-Louis, Quebec, Canada, G1W 4R4
      • Centre de Recherche Saint-Louis
• Czechia
  • Brno, Czechia, 638 00
    • Revmatologie s.r.o.
  • Hostivice, Czechia, 253 01
    • ARTMEDI UPD s.r.o.
  • Pardubice, Czechia, 530 02
    • ARTHROMED s.r.o.
  • Praha, Czechia, 140 59
    • Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka
  • Praha 11, Czechia, 148 00
    • Medifin a.s, Šustova
  • Praha 4, Czechia, 140 00
    • Revmatologicka ambulance
  • Sokolov, Czechia, 356 01
    • Revmatologicka ambulance
  • Zlin, Czechia, 760 01
    • PV-MEDICAL s.r.o.
• Estonia
  • Tallinn, Estonia, 10117
    • Innomedica Medical and Research Centre
  • Tallinn, Estonia, 11412
    • East Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital
  • Tartu, Estonia, 50106
    • Clinical Research Centre Ltd
• France
  • Boulogne, France, 92100
    • Hôpital Ambroise-Paré
  • Créteil, France, 94010
    • Hopital Henri Mondor
  • Orléans Cedex 2, France, 45067
    • IPROS - CHR ORLEANS - Hôpital de la Source
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75651
    • Groupe Hospitalier Pitié- Salpétrière
• Germany
  • Berlin, Germany, 12203
    • Charité - Universitätsmedizin Berlin
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Frankfurt, Germany, 60528
    • Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH
  • Hamburg, Germany, 22081
    • Schön Klink Hamburg-Eilbek
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Herne, Germany, 44649
    • Rheumazentrum Ruhrgebiet
• Hungary
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Budapest, Hungary, 1036
    • Qualiclinic Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Veszprém, Hungary, 8200
    • Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Leiden Universitair Medisch Centrum
  • Maastricht, Netherlands, 6229 HX
    • Academisch Ziekenhuis Maastricht
• Poland
  • Bialystok, Poland, 15-099
    • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • Bialystok, Poland, 15-351
    • NZOZ Osteo-Medic sc A. Racewicz J. Supronik
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
  • Gdynia, Poland, 81-537
    • Synexus SCM Sp. z o.o.
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Pawel Hrycaj
  • Torun, Poland, 87-100
    • NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
  • Wroclaw, Poland, 50-088
    • Synexus SCM Sp. z o.o.
• Romania
  • Braila, Romania, 810019
    • Cristei R. Rodica - Private Medical Practice
  • Bucharest, Romania, 011172
    • Sf. Maria Clinical Hospital
  • Cluj-Napoca, Romania, 400006
    • Emergency County Clinical Hospital
  • Galati, Romania, 800578
    • Sf Apostol Andrei Emergency Clinical County Hospital
  • Iasi, Romania, 700127
    • RK Medcenter SRL
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital 1
  • Kazan, Russian Federation, 420103
    • Research Medical Complex Vashe Zdorovie
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Regional Clinical Hospital
  • Moscow, Russian Federation, 115522
    • Federal State Budget Institution "Rheumatology Research Institute RAMS"
  • Nizhniy Novgorod, Russian Federation, 603005
    • Nizhniy Novgorod State Medical Academy of Roszdrav
  • Smolensk, Russian Federation, 214025
    • Departmental Hospital at Smolensk Station RZhD JSC
  • Vladimir, Russian Federation, 600023
    • Regional Clinical Hospital
• Slovakia
  • Piestany, Slovakia, 921 12
    • Narodny ustav reumatickych chorob
  • Poprad, Slovakia, 058 01
    • MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruna
  • Barcelona, Spain, 08907
    • Hospital De Bellvitge
  • Cordoba, Spain, 14001
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Sabadell, Spain, 08208
    • Corporació Sanitària Parc Taulí de Sabadell
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n
• Sweden
  • Malmö, Sweden, 20502
    • Skånes Universitetssjukhus- Malmö
• United Kingdom
  • Barnsley, United Kingdom, S75 2EP
    • Barnsley Hospital
  • Bath, United Kingdom, BA1 1RL
    • Royal National Hospital for Rheumatic Diseases
  • Leeds, United Kingdom, LS7 4SA
    • Chapel Allerton Hospital
  • Oxford, United Kingdom, OX3 7LD
    • Nuffield Orthopaedic Centre
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Sun Valley Arthritis Center
  • California
    • La Jolla, California, United States, 92093-0943
      • University of California, San Diego
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • San Francisco, California, United States, 94143-0326
      • UCSF Arthritis Center
  • Florida
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Centers, Inc
    • Tampa, Florida, United States, 33614
      • Burnette & Silverfield, MDS PLC
    • Vero Beach, Florida, United States, 32960
      • Alastair Kennedy, MD Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation
  • Maryland
    • Cumberland, Maryland, United States, 21502
      • Klein and Associates MD, PA
    • Hagerstown, Maryland, United States, 21740
      • Klein and Associates MD, PA
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Clinical Pharmacology Study Group
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Saint Paul Rheumatology, PA
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Systems
    • Dayton, Ohio, United States, 45417
      • STAT Research, Inc.
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Arthritis Clinic
    • Memphis, Tennessee, United States, 38119
      • Ramesh C Gupta MD
  • Texas
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospitals and Clinics
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Rheumatology and Immunotherapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have a documented diagnosis of ankylosing spondylitis as defined by low back pain and stiffness, which improves with exercise, but is not relieved by rest for more than 3 months prior to screening. At the completion of screening procedures, a documented diagnosis of definite active AS, as defined by the modified New York criteria (1984) whereby both criteria, at least 1 radiographic criterion and at least 1 clinical criterion, must be met
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is ≥ 4
• Total back pain is ≥ 4
• On stable dose of AS medication (or lack of medication) prior to randomization and through week 24

Exclusion Criteria:

- Prior treatment with a Tumor Necrosis Factor (TNF) blocker and any biologic treatment for AS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apremilast 20 mg; Apremilast 20 mg was taken orally twice a day (BID)	Drug: Apremilast tablet 20 mg; Apremilast 20 mg was taken orally twice a day (BID); Other Names: Otezla; CC-10004
Experimental: Apremilast 30 mg; Apremilast 30 mg was taken orally twice a day	Drug: Apremilast tablet 30 mg BID; Apremilast 30 mg was taken orally twice a day; Other Names: Otezla; CC-10004
Placebo Comparator: Placebo; Identically matched placebo tablets were taken orally twice a day	Drug: Placebo; Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16	ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active; Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain"; Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability; Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24	The BASFI is a composite score based on a self-administered survey of 10 questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the degree of mobility and functional ability. The survey consists of 8 questions regarding function in AS and the last 2 reflect the ability to manage everyday life. The patient marks a box with an X on a 0 to 10 unit NRS for 10 questions; the left-hand box of 0 = easy; the right-hand box = impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. The overall score is the mean of the 10 items and ranges from 0 to 10. A higher score correlates to reduced functional ability.	Baseline and Week 24
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24	The BASDAI is a composite score based on a participant self-administered survey of six questions measured using a 0 to 10 unit numerical rating scale (NRS) that assessed the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant was asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater was considered to be indicative of active AS disease.	Baseline and Week 24
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24	ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active; Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain"; Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability; Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)	Baseline and Week 24
Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24	The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consisted of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0-18 with higher scores indicating worse quality of life.	Baseline and Week 24
Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24	The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was 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 (based on US general population with mean of 50 and standard deviation of 10) were used in analyses. Higher scores indicate a higher level of functioning. The PCS encompasses physical functioning, role-physical, and bodily pain, as well as general health and vitality. A positive change from baseline score indicates an improvement	Baseline and Week 24
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24	The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) were measured and normalized on 0 to 10 unit NRS. The average of these scores was the total BASMI score, ranging from 0-10 with higher values indicating more severe limitation in spinal mobility.	Baseline and Week 24
Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260	The Modified Stoke Ankylosing Spondylitis Spine Score is a scoring method used to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine. The m-SASSS scores 0-3. 0 = No abnormality, 1 = Erosion, Sclerosis or Squaring, 2 = Syndesmophyte, 3 = Total bony Bridging at each Site. An increase in the m-SASSS indicated a worsening of AS disease.	Baseline to Week 104 and 260
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase	A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.	From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period	A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.	Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.
• Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.
• Taylor PC, van der Heijde D, Landewé R, McCue S, Cheng S, Boonen A. A Phase III Randomized Study of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Active Ankylosing Spondylitis. J Rheumatol. 2021 Aug;48(8):1259-1267. doi: 10.3899/jrheum.201088. Epub 2021 Feb 15.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2012
• Primary Completion (Actual): February 24, 2014
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: spondylitis; spondyloarthritis; Spondyloarthropathy; Oral preparation
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Thalidomide; Apremilast
• Other Study ID Numbers: CC-10004-AS-001; 2011-001555-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)