Back to resultsEfficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis. (FOREMOST)
Primary Purpose
Arthritis, Psoriatic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Apremilast (CC-10004)
Apremilast (CC-10004) Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Psoriatic focused on measuring Oligoarthritis, PsA, Apremilast, Oral tablet, Background therapy, Standard of care
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 yrs, male or female subject
- Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
- SJC AND TJC must be >1 and ≤ 4
- For all regions, the local Regulatory Label for treatment with apremilast must be followed.
- Stable doses of protocol-allowed PsA medications
- General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
- Comply with protocol-required contraception measures
- Subject meets the Classification Criteria for Psoriatic Arthritis [CASPAR] Criteria for PsA at the Screening visit
Exclusion Criteria:
- Prior use of >2 csDMARD to treat PsA
- Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
- Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
- Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
- Prior use of cyclosporine.
- Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
- Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Sites / Locations
- Arizona Arthritis and Rheumatology Research, PLLC
- Covina Arthritis Clinic
- Encino Research Center
- Providence Medical Foundation
- Rheumatology Center of San Diego PC
- East Bay Rheumatology Medical
- Millennium Clinical Trials
- Robin K Dore MD Inc
- Inland Rheumatology Clinical Trials Inc
- Denver Arthritis Clinic PC
- Arthritis and Rheumatic Disease Specialties
- Clinical Research of West Florida, Inc
- Center for Rheumatology, Immunology, and Arthritis
- University of Florida College of Medicine
- Integral Rheumatology and Immunology Specialists
- Florida Center For Dermatology
- Clinical Research of West Florida Inc
- Carol and Frank Morsani Center for Advanced Health Care
- Baycare Medical Group Inc
- North Georgia Rheumatology Group PC
- RC Rsearch Inc
- OrthoIllinois
- Graves Gilbert Clinic
- Clinical Trials Management LLC
- Klein and Associates MD, PA - Cumberland
- Klein and Associates MD PA
- Clinical Pharmacology Study Group
- Advanced Rheumatology PC
- Arthritis and Rheumatology Center of Michigan
- Clinical Research Institute of Michigan
- Saint Paul Rheumatology PA
- Arthritis, Rheumatic, and Back Disease Associates
- New York University Langone Medical Center
- University of Rochester
- Joint and Muscle Research Institute
- University Hospitals Cleveland Medical Center
- Paramount Medical Research and Consulting LLC
- Arthritis and Osteoporosis Center of Southwest Ohio
- Health Research of Oklahoma
- Altoona Center for Clinical Research
- Arthritis Group
- Rhode Island Hospital
- Piedmont Arthritis Clinic
- West Tennessee Research Institute, LLC
- Accurate Clinical Research Incorporated Baytown
- Precision Comprehensive Clinical Research Solutions
- Texas Arthritis Center PA
- West Texas Clinical Research
- Advanced Rheumatology of Houston
- Center for Clinical Studies
- Seattle Rheumatology Associates
- Rheumatology and Pulmonary Clinic
- West Virginia Research Institute
- West Virginia Research Institute
- Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
- Krankenhaus Hietzing
- Centre Hospitalier Universitaire Brugmann
- Hopital Erasme
- Universitair Ziekenhuis Leuven
- Ziekenhuis Netwerk Antwerpen Jan Palfijn
- Manitoba Clinic
- Ottawa Hospital
- Toronto Western Hospital
- Dr. Sabeen Anwar Medicine Professional Corporation
- Institut de Rhumatologie de Montreal
- Centre Hospitalier Regional dOrleans
- Hopital Lariboisiere
- Assistance Publique- Hopitaux de Paris AP-HP
- CH Toulouse Hopital Pierre-Paul Riquet
- Praxis fur Rheumatologie - Amberg
- Kerckhoff-Klinik gGmbH
- Charité Campus Mitte
- Universitaetsklinikum Duesseldorf
- Service Rheuma Erfurt
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
- Universitatsklinikum Freiburg
- Rheumazentrum Ruhrgebiet
- Universitaetsklinikum Tuebingen
- AO Ospedale Policlinico Consorziale Di Bari
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Universita degli studi Messina
- IRCCS Ospedale San Raffaele
- Azienda Ospedaliera Universitaria Federico II
- Policlinico San Matteo Universita Di Pavia
- Azienda Ospedaliera Universitaria Pisana
- Fondazione Policlinico Tor Vergata
- Humanitas Research Hospital Humanitas Mirasole
- Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
- Medisch Spectrum Twente
- Erasmus Medisch Centrum
- Kazan State Medical University
- Kursk Regional Clinical Hospital
- Research Institute of Rheumatology named after V.A.Nasonova
- Moscow Regional Research Institute n.a. Vladimirsky
- Research Institute of Clinical and Experimental Lymphology
- Republican Hospital na VA Baranov
- Municipal Budgetary Healthcare Institution City Emergency Hospital
- Medical Center Sanavita
- Mechnikov North-Western State Medical University
- Tomsk Regional Clinical Hospital
- Hospital Universitario de Cruces
- Hospital Galdakao-Usansolo
- Hospital Universitario Insular de Gran Canaria
- Hospital Universitario Ramon y Cajal
- Hospital Universitario La Paz
- Hospital de Merida
- Royal Berkshire Hospital
- Eastbourne District General Hospital
- Western General Hospital
- Kings College Hospital
- Luton and Dunstable University Hosptial
- Torbay Hospital
- Royal Cornwall Hospitals Trust
- Wolverhampton Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD
Placebo
Arm Description
Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
Outcomes
Primary Outcome Measures
Proportion of subjects who achieved a clinical state of minimal disease activity defined MDA-Joints)
Minimal disease activity by MDA joints
Secondary Outcome Measures
Proportion of subjects with cDAPSA remission or low activity
cDAPSA Remission or Low Disease Activity
Proportion of subjects with SJC ≤ 1
Swollen Joint Count (SJC)
Proportion of subjects with TJC ≤ 1
Tender Joint Count (TJC)
Proportion of subjects with improvement in the PsAID-12 score
PsAID-12 Response
Proportion of subjects with improvement in the PASDAS score
PASDAS Response
Proportion of subjects with improvement in the Patient Global Assessment of Disease Activity
Patient's Global Assessment of Disease Activity
Proportion of subjects with improvement in the Patient Global Assessment Pain
Patient's Global Assessment of Disease Pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03747939
Brief Title
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
Acronym
FOREMOST
Official Title
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDS and/or ≤ 1 Conventional Synthetic DMARD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
July 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. In previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. This study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). About 285 patients worldwide will take part in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
Keywords
Oligoarthritis, PsA, Apremilast, Oral tablet, Background therapy, Standard of care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD
Arm Type
Experimental
Arm Description
Subjects will take ORAL tables of apremilast for up to 48 weeks (30 mg twice daily). Subjects may also receive stable doses of background therapy (standard or care) with NSAIDs, glucorticosteroids and 1 csDMARD as permitted by protocol. After wk. 24, subjects may change the dose /type of permitted Psoriatic Arthritis medications
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take placebo for up to 24 weeks (twice daily). Subjects may also receive stable doses of background therapy ( standard of care) with NSAIDs, glucocorticosteroids and 1 csDMARD as permitted by protocol. After wk 24, subjects may change the dose /type of permitted PsA medications.
Intervention Type
Drug
Intervention Name(s)
Apremilast (CC-10004)
Other Intervention Name(s)
Otezla
Intervention Description
Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive "dummy" titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles.
Intervention Type
Other
Intervention Name(s)
Apremilast (CC-10004) Placebo
Intervention Description
Subjects randomized to placebo will receive "dummy" dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles
Primary Outcome Measure Information:
Title
Proportion of subjects who achieved a clinical state of minimal disease activity defined MDA-Joints)
Description
Minimal disease activity by MDA joints
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of subjects with cDAPSA remission or low activity
Description
cDAPSA Remission or Low Disease Activity
Time Frame
Week 16
Title
Proportion of subjects with SJC ≤ 1
Description
Swollen Joint Count (SJC)
Time Frame
Week 16
Title
Proportion of subjects with TJC ≤ 1
Description
Tender Joint Count (TJC)
Time Frame
Week 16
Title
Proportion of subjects with improvement in the PsAID-12 score
Description
PsAID-12 Response
Time Frame
Week 16
Title
Proportion of subjects with improvement in the PASDAS score
Description
PASDAS Response
Time Frame
Week 16
Title
Proportion of subjects with improvement in the Patient Global Assessment of Disease Activity
Description
Patient's Global Assessment of Disease Activity
Time Frame
Week 16
Title
Proportion of subjects with improvement in the Patient Global Assessment Pain
Description
Patient's Global Assessment of Disease Pain
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 yrs, male or female subject
Subjects must have signs and symptoms of PsA ≤5 years duration at the time of the Screening Visit
SJC AND TJC must be >1 and ≤ 4
For all regions, the local Regulatory Label for treatment with apremilast must be followed.
Stable doses of protocol-allowed PsA medications
General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
Comply with protocol-required contraception measures
Subject meets the Classification Criteria for Psoriatic Arthritis [CASPAR] Criteria for PsA at the Screening visit
Exclusion Criteria:
Prior use of >2 csDMARD to treat PsA
Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
Prior use of cyclosporine.
Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Covina Arthritis Clinic
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Rheumatology Center of San Diego PC
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
East Bay Rheumatology Medical
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Millennium Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Robin K Dore MD Inc
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheumatology Clinical Trials Inc
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Clinic PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Clinical Research of West Florida, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Center for Rheumatology, Immunology, and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Integral Rheumatology and Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Florida Center For Dermatology
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32080
Country
United States
Facility Name
Clinical Research of West Florida Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Facility Name
Carol and Frank Morsani Center for Advanced Health Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Baycare Medical Group Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
North Georgia Rheumatology Group PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
RC Rsearch Inc
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
OrthoIllinois
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Klein and Associates MD, PA - Cumberland
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
Advanced Rheumatology PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Arthritis and Rheumatology Center of Michigan
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Saint Paul Rheumatology PA
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Arthritis, Rheumatic, and Back Disease Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Joint and Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Paramount Medical Research and Consulting LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Arthritis and Osteoporosis Center of Southwest Ohio
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
West Tennessee Research Institute, LLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Accurate Clinical Research Incorporated Baytown
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Texas Arthritis Center PA
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
West Texas Clinical Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
92103
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Rheumatology and Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
West Virginia Research Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
West Virginia Research Institute
City
South Charleston
State/Province
West Virginia
ZIP/Postal Code
25309
Country
United States
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Krankenhaus Hietzing
City
Vienna
ZIP/Postal Code
1130
Country
Austria
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Ziekenhuis Netwerk Antwerpen Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Dr. Sabeen Anwar Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Institut de Rhumatologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre Hospitalier Regional dOrleans
City
Orleans cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Assistance Publique- Hopitaux de Paris AP-HP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CH Toulouse Hopital Pierre-Paul Riquet
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Praxis fur Rheumatologie - Amberg
City
Amberg
ZIP/Postal Code
92224
Country
Germany
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Service Rheuma Erfurt
City
Erfurt
ZIP/Postal Code
99096
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
AO Ospedale Policlinico Consorziale Di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Universita degli studi Messina
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico San Matteo Universita Di Pavia
City
Pavia 2
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Fondazione Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Humanitas Research Hospital Humanitas Mirasole
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Kursk Regional Clinical Hospital
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
Research Institute of Rheumatology named after V.A.Nasonova
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Moscow Regional Research Institute n.a. Vladimirsky
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Research Institute of Clinical and Experimental Lymphology
City
Novosibirsk
ZIP/Postal Code
630061
Country
Russian Federation
Facility Name
Republican Hospital na VA Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Municipal Budgetary Healthcare Institution City Emergency Hospital
City
Rostov-on-don
ZIP/Postal Code
344029
Country
Russian Federation
Facility Name
Medical Center Sanavita
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Mechnikov North-Western State Medical University
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Tomsk Regional Clinical Hospital
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
Facility Name
Hospital Universitario de Cruces
City
Baracaldo
State/Province
País Vasco
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital de Merida
City
Merida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Royal Berkshire Hospital
City
Derby
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Luton and Dunstable University Hosptial
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay South Devon
ZIP/Postal Code
TQ12 3JX
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals Trust
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Wolverhampton Road
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
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
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Efficacy, Safety, and Tolerability Study of Apremilast to Treat Early Oligoarticular Psoriatic Arthritis.
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