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

Primary Purpose

Ankylosing Spondyloarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast tablet 20 mg
Apremilast tablet 30 mg BID
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondyloarthritis focused on measuring spondylitis, spondyloarthritis, Spondyloarthropathy, Oral preparation

Eligibility Criteria

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

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

Sites / Locations

  • Sun Valley Arthritis Center
  • University of California, San Diego
  • Desert Medical Advances
  • UCSF Arthritis Center
  • Advent Clinical Research Centers, Inc
  • Burnette & Silverfield, MDS PLC
  • Alastair Kennedy, MD Research
  • Northwestern Medical Faculty Foundation
  • Klein and Associates MD, PA
  • Klein and Associates MD, PA
  • Clinical Pharmacology Study Group
  • Saint Paul Rheumatology, PA
  • MetroHealth Medical Systems
  • STAT Research, Inc.
  • Altoona Center for Clinical Research
  • The Arthritis Clinic
  • Ramesh C Gupta MD
  • Austin Regional Clinic
  • University of Utah Hospitals and Clinics
  • Rheumatology and Immunotherapy Center
  • Southern Clinical Research
  • Emeritus Research
  • Coastal Joint Care
  • Royal Perth Hospital
  • The Queen Elizabeth Hospital
  • Krankenhaus Wien-Hietzing
  • Diagnostic and Consulting Center Sv. Pantaleymon
  • National Multiprofile Transport Hospital Tzar Boris III
  • 17 Diagnostic and Consulting Centre
  • Military Medical Academy - MHAT
  • Diagnostic Consulting Center N4
  • Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)
  • Nexus Clinical Research
  • Cividino Medicine Professional Corporation
  • Dr. William G. Bensen Medicine Professional Corporation
  • Credit Valley Professional Building
  • The Arthritis Program Research Group Inc.
  • Rheumatology Research Associates
  • Toronto Western Hospital
  • Centre de Recherche Saint-Louis
  • Revmatologie s.r.o.
  • ARTMEDI UPD s.r.o.
  • ARTHROMED s.r.o.
  • Medifin a.s, Šustova
  • Revmatologicka Ambulance
  • Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka
  • Revmatologicka Ambulance
  • PV-Medical s.r.o.
  • Innomedica Medical and Research Centre
  • East Tallinn Central Hospital
  • Clinical Research Centre Ltd
  • Tartu University Hospital
  • Hopital Ambroise-Pare
  • Hopital Henri Mondor
  • IPROS - CHR ORLEANS - Hôpital de la Source
  • Hopital Cochin
  • Groupe Hospitalier Pitié- Salpétrière
  • Charite - Universitätsmedizin Berlin
  • Universitatsklinikum Erlangen
  • Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH
  • Schön Klink Hamburg-Eilbek
  • Universitatsklinikum Heidelberg
  • Rheumazentrum Ruhrgebiet
  • Qualiclinic kft
  • Synexus Magyarország Kft.
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Pest Megyei Flor Ferenc Korhaz
  • Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet
  • Leiden Universitair Medisch Centrum
  • Academisch Ziekenhuis Maastricht
  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • NZOZ Osteo-Medic sc A. Racewicz J. Supronik
  • Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
  • Synexus SCM Sp. z o.o.
  • Zespol Poradni Specjalistycznych
  • Prywatna Praktyka Lekarska Pawel Hrycaj
  • NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
  • Synexus SCM Sp. z o.o.
  • Cristei R. Rodica - Private Medical Practice
  • Sf. Maria Clinical Hospital
  • Emergency County Clinical Hospital
  • Sf Apostol Andrei Emergency Clinical County Hospital
  • RK Medcenter SRL
  • Sverdlovsk Regional Clinical Hospital 1
  • Research Medical Complex Vashe Zdorovie
  • Kemerovo Regional Clinical Hospital
  • Federal State Budget Institution "Rheumatology Research Institute RAMS"
  • Nizhniy Novgorod State Medical Academy of Roszdrav
  • Departmental Hospital at Smolensk Station RZhD JSC
  • Regional Clinical Hospital
  • Narodny ustav reumatickych chorob
  • MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia
  • Hospital Universitario a Coruna
  • Hospital de Bellvitge
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario Gregorio Maranon
  • Corporacio Sanitaria Parc Tauli de Sabadell
  • Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n
  • Skånes Universitetssjukhus- Malmö
  • Barnsley Hospital
  • Royal National Hospital for Rheumatic Diseases
  • Chapel Allerton Hospital
  • Nuffield Orthopaedic Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Apremilast 20 mg

Apremilast 30 mg

Placebo

Arm Description

Apremilast 20 mg was taken orally twice a day (BID)

Apremilast 30 mg was taken orally twice a day

Identically matched placebo tablets were taken orally twice a day

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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)
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.
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
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.
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.
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.
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.

Full Information

First Posted
April 20, 2012
Last Updated
April 28, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01583374
Brief Title
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
Acronym
POSTURE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2012 (Actual)
Primary Completion Date
February 24, 2014 (Actual)
Study Completion Date
October 25, 2018 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondyloarthritis
Keywords
spondylitis, spondyloarthritis, Spondyloarthropathy, Oral preparation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apremilast 20 mg
Arm Type
Experimental
Arm Description
Apremilast 20 mg was taken orally twice a day (BID)
Arm Title
Apremilast 30 mg
Arm Type
Experimental
Arm Description
Apremilast 30 mg was taken orally twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identically matched placebo tablets were taken orally twice a day
Intervention Type
Drug
Intervention Name(s)
Apremilast tablet 20 mg
Other Intervention Name(s)
Otezla; CC-10004
Intervention Description
Apremilast 20 mg was taken orally twice a day (BID)
Intervention Type
Drug
Intervention Name(s)
Apremilast tablet 30 mg BID
Other Intervention Name(s)
Otezla; CC-10004
Intervention Description
Apremilast 30 mg was taken orally twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16
Description
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)
Time Frame
Baseline and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24
Description
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)
Time Frame
Baseline and Week 24
Title
Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
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
Description
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
Time Frame
Baseline and Week 24
Title
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260
Description
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.
Time Frame
Baseline to Week 104 and 260
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase
Description
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.
Time Frame
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.
Title
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period
Description
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.
Time Frame
Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Sun Valley Arthritis Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0943
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
UCSF Arthritis Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0326
Country
United States
Facility Name
Advent Clinical Research Centers, Inc
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Burnette & Silverfield, MDS PLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Alastair Kennedy, MD Research
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Klein and Associates MD, PA
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Klein and Associates MD, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Saint Paul Rheumatology, PA
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
MetroHealth Medical Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Arthritis Clinic
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
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Rheumatology and Immunotherapy Center
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Southern Clinical Research
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Coastal Joint Care
City
Maroochydore
ZIP/Postal Code
4558
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6849
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Krankenhaus Wien-Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Diagnostic and Consulting Center Sv. Pantaleymon
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
National Multiprofile Transport Hospital Tzar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
17 Diagnostic and Consulting Centre
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
Military Medical Academy - MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Diagnostic Consulting Center N4
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Nexus Clinical Research
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5EB
Country
Canada
Facility Name
Cividino Medicine Professional Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Dr. William G. Bensen Medicine Professional Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N1Y2
Country
Canada
Facility Name
Credit Valley Professional Building
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
The 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
K1H1A2
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 258
Country
Canada
Facility Name
Centre de Recherche Saint-Louis
City
Saint-Louis
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
ARTMEDI UPD s.r.o.
City
Hostivice
ZIP/Postal Code
253 01
Country
Czechia
Facility Name
ARTHROMED s.r.o.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Medifin a.s, Šustova
City
Praha 11
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Revmatologicka Ambulance
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka
City
Praha
ZIP/Postal Code
140 59
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
10117
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
11412
Country
Estonia
Facility Name
Clinical Research Centre Ltd
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Hopital Ambroise-Pare
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
IPROS - CHR ORLEANS - Hôpital de la Source
City
Orléans Cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Groupe Hospitalier Pitié- Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Charite - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Schön Klink Hamburg-Eilbek
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Qualiclinic kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Magyarország 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
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Leiden Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
City
Bialystok
ZIP/Postal Code
15-099
Country
Poland
Facility Name
NZOZ Osteo-Medic sc A. Racewicz J. Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Synexus SCM Sp. z o.o.
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Synexus SCM Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Cristei R. Rodica - Private Medical Practice
City
Braila
ZIP/Postal Code
810019
Country
Romania
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
RK Medcenter SRL
City
Iasi
ZIP/Postal Code
700127
Country
Romania
Facility Name
Sverdlovsk Regional Clinical Hospital 1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Medical Complex Vashe Zdorovie
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Federal State Budget Institution "Rheumatology Research Institute RAMS"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Nizhniy Novgorod State Medical Academy of Roszdrav
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Facility Name
Departmental Hospital at Smolensk Station RZhD JSC
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Hospital Universitario a Coruna
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli de Sabadell
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Skånes Universitetssjukhus- Malmö
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Barnsley Hospital
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Royal National Hospital for Rheumatic Diseases
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Nuffield Orthopaedic Centre
City
Oxford
ZIP/Postal Code
OX3 7LD
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
30018799
Citation
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.
Results Reference
background
PubMed Identifier
31077258
Citation
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.
Results Reference
background
PubMed Identifier
33589554
Citation
Taylor PC, van der Heijde D, Landewe 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.
Results Reference
derived

Learn more about this trial

Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis

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