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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1224-0216 | Registry Identifier | WHO | |
| 2018-002735-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast 30 mg twice daily ± NSAIDs, ≤ 1 csDMARD | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast (CC-10004) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 | MDA is defined as tender joint counts (TJC) ≤ 1 and SJC ≤ 1 plus 3 of the following 5 criteria:
| Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA) | The cDAPSA score is based on the numerical summation of 4 disease activity variables: tender and swollen joints, patient's global assessments of disease activity and assessment of pain (VAS). The cDAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. cDAPSA remission is defined as a DAPSA score ≤ 4 and low disease activity is defined as a cDAPSA score > 4 but ≤ 13). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis and Rheumatology Research, PLLC | Mesa | Arizona | 85202 | United States | ||
| Covina Arthritis Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39164067 | Background | Gossec L, Coates LC, Gladman DD, Aelion JA, Vasandani J, Pinter A, Merola JF, Kavanaugh A, Reddy J, Wang R, Brunori M, Klyachkin Y, Deignan C, Mease PJ. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Oct 21;83(11):1480-1488. doi: 10.1136/ard-2024-225833. | |
| 42384964 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
Participants with early oligoarticular psoriatic arthritis were randomized in a 2:1 ratio to receive apremilast or placebo. At week 16, participants with no swollen joint count (SJC) improvement could have escaped early to receive apremilast 30 mg BID. At week 24, eligible participants entered the open-label extension phase to receive apremilast 30 mg BID up to week 48. Of the 310 enrolled participants, 2 were enrolled in error and did not receive any dose of investigational product.
Participants were enrolled at 80 study centers in Austria, Belgium, Canada, France, Germany, Italy, Spain, the United Kingdom, and the United States from 31 December 2018 to the last participant's last study visit on 05 July 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-controlled Phase: Placebo | Participants were randomized to receive placebo twice daily (BID) from day 1. Participants could also have received stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Phase (Weeks 0 - 24) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2021 | Dec 14, 2023 |
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|
|
| Apremilast (CC-10004) Placebo | Other | 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 |
|
| Week 16 |
| Percentage of Participants With SJC ≤ 1 at Week 16 | The SJC was based on 66 joints and at week 16 is based on the sentinel joints (i.e., the joints that were affected at baseline). A SJC response is defined as a count ≤ 1. | Week 16 |
| Percentage of Participants With TJC ≤ 1 at Week 16 | The TJC was based on 68 joints and at week 16 was based on the sentinel joints (i.e., the joints that were affected at baseline). A TJC response is defined as a count ≤ 1. | Week 16 |
| Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16 | The Patient's Global Assessments of Disease Activity is an assessment of how active a participant's psoriatic arthritis was on average during the last week. It was assessed on a VAS ranging from 0 to 100 mm, with a higher score indicating more disease activity. A response is defined as a score ≤ 20 mm. | Week 16 |
| Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16 | The Patients Pain VAS is the participant's assessment of how much pain they had, on average, during the last week in their joints due to psoriatic arthritis. The VAS score ranges from 0 to 100 mm, with a higher score indicating more pain. | Week 16 |
| Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16 | The PsAID-12 Questionnaire is a 12-item, self-administered questionnaire that reflects the impact of psoriatic arthritis from the perspective of the participant. The overall score ranges from 0 (best status) to 10 (worst status), with a cut-off ≤ 4 representing patient-acceptable symptom state. Analysis was based on a mixed-effects model for repeated measures (MMRM), which included treatment group, time, treatment group by time interaction, prior/concomitant use of csDMARD (naive, prior use only, both prior and concomitant use) and baseline glucocorticosteroid use (yes/no) per IWRS data as factors, and baseline value as a covariate. | Baseline and Week 16 |
| Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16 | The PASDAS is a weighted index comprising assessments of joints, function, acute-phase response, quality of life, and patient and physician VAS. The score range of the PASDAS is 0 - 10, with worse disease activity represented by higher scores. A good response is defined as a PASDAS score of ≤ 3.2 with improvement from baseline ≥ 1.6 points. A moderate response is defined as a PASDAS score > 3.2 with improvement from baseline ≥ 1.6 points; or PASDAS score < 5.4 with improvement from baseline ≥ 0.8 but < 1.6 points. | Baseline and Week 16 |
| Covina |
| California |
| 91722 |
| United States |
| Encino Research Center | Encino | California | 91436 | United States |
| Providence Medical Foundation | Fullerton | California | 92835 | United States |
| Rheumatology Center of San Diego PC | San Diego | California | 92128 | United States |
| East Bay Rheumatology Medical | San Leandro | California | 94578 | United States |
| Millennium Clinical Trials | Thousand Oaks | California | 91360 | United States |
| Robin K Dore MD Inc | Tustin | California | 92780 | United States |
| Inland Rheumatology Clinical Trials Inc | Upland | California | 91786 | United States |
| Denver Arthritis Clinic PC | Denver | Colorado | 80230 | United States |
| Arthritis and Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States |
| Clinical Research of West Florida, Inc | Clearwater | Florida | 33765 | United States |
| Center for Rheumatology, Immunology, and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Integral Rheumatology and Immunology Specialists | Plantation | Florida | 33324 | United States |
| Florida Center For Dermatology | Saint Augustine | Florida | 32080 | United States |
| Clinical Research of West Florida Inc | Tampa | Florida | 33606-1246 | United States |
| Carol and Frank Morsani Center for Advanced Health Care | Tampa | Florida | 33612 | United States |
| Baycare Medical Group Inc | Tampa | Florida | 33614 | United States |
| North Georgia Rheumatology Group PC | Lawrenceville | Georgia | 30046 | United States |
| RC Rsearch Inc | Hinsdale | Illinois | 60521 | United States |
| OrthoIllinois | Rockford | Illinois | 61114 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Clinical Trials Management LLC | Metairie | Louisiana | 70006 | United States |
| Klein and Associates MD, PA - Cumberland | Cumberland | Maryland | 21502 | United States |
| Klein and Associates MD PA | Hagerstown | Maryland | 21740 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| Advanced Rheumatology PC | Lansing | Michigan | 48910 | United States |
| Arthritis and Rheumatology Center of Michigan | Lansing | Michigan | 48910 | United States |
| Clinical Research Institute of Michigan | Saint Clair Shores | Michigan | 48081 | United States |
| Saint Paul Rheumatology PA | Eagan | Minnesota | 55121 | United States |
| Arthritis, Rheumatic, and Back Disease Associates | Voorhees Township | New Jersey | 08043 | United States |
| New York University Langone Medical Center | New York | New York | 10003 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Joint and Muscle Research Institute | Charlotte | North Carolina | 28204 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Paramount Medical Research and Consulting LLC | Middleburg Heights | Ohio | 44130 | United States |
| Arthritis and Osteoporosis Center of Southwest Ohio | Middletown | Ohio | 45044 | United States |
| Health Research of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | United States |
| West Tennessee Research Institute, llc | Jackson | Tennessee | 38305 | United States |
| Accurate Clinical Research Incorporated Baytown | Baytown | Texas | 77521 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| Texas Arthritis Center PA | El Paso | Texas | 79902 | United States |
| West Texas Clinical Research | Lubbock | Texas | 79410 | United States |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | United States |
| Center for Clinical Studies | Webster | Texas | 92103 | United States |
| Seattle Rheumatology Associates | Seattle | Washington | 98104 | United States |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | 25801 | United States |
| West Virginia Research Institute | Morgantown | West Virginia | 26505 | United States |
| West Virginia Research Institute | South Charleston | West Virginia | 25309 | United States |
| Universitaetsklinikum Allgemeines Krankenhaus Wien Universitaetsklinik fur Innere Medizin I | Vienna | 1090 | Austria |
| Krankenhaus Hietzing | Vienna | 1130 | Austria |
| Centre Hospitalier Universitaire Brugmann | Brussels | 1020 | Belgium |
| Hopital Erasme | Brussels | 1070 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| Ziekenhuis Netwerk Antwerpen Jan Palfijn | Merksem | 2170 | Belgium |
| Manitoba Clinic | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Dr Sabeen Anwar Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Institut de Rhumatologie de Montreal | Montreal | Quebec | H2L 1S6 | Canada |
| Centre Hospitalier Regional dOrleans | Orléans | 45067 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Assistance Publique- Hopitaux de Paris AP-HP | Paris | 75013 | France |
| CH Toulouse Hopital Pierre-Paul Riquet | Toulouse | 31059 | France |
| Praxis fur Rheumatologie - Amberg | Amberg | 92224 | Germany |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | 61231 | Germany |
| Charite - Universitaetsmedizin Berlin, Campus Mitte | Berlin | 10117 | Germany |
| Universitaetsklinikum Duesseldorf | Düsseldorf | 40225 | Germany |
| Service Rheuma Erfurt | Erfurt | 99096 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt/Main | Frankfurt am Main | 60590 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Rheumazentrum Ruhrgebiet | Herne | 44649 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| AO Ospedale Policlinico Consorziale Di Bari | Bari | 70124 | Italy |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Universita degli studi Messina | Messina | 98125 | Italy |
| IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Policlinico San Matteo Universita Di Pavia | Pavia | 27100 | Italy |
| Azienda Ospedaliera Universitaria Pisana | Pisa | 56126 | Italy |
| Fondazione Policlinico Tor Vergata | Rome | 00133 | Italy |
| Humanitas Research Hospital Humanitas Mirasole | Rozzano MI | 20089 | Italy |
| Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma | Verona | 37126 | Italy |
| Medisch Spectrum Twente | Enschede | 7512 KZ | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 CN | Netherlands |
| Kazan State Medical University | Kazan' | 420097 | Russia |
| Kursk Regional Clinical Hospital | Kursk | 305007 | Russia |
| Research Institute of Rheumatology named after V A Nasonova | Moscow | 115522 | Russia |
| Moscow Regional Research Institute n a Vladimirsky | Moscow | 129110 | Russia |
| Research Institute of Clinical and Experimental Lymphology | Novosibirsk | 630061 | Russia |
| Republican Hospital na VA Baranov | Petrozavodsk | 185019 | Russia |
| Municipal Budgetary Healthcare Institution City Emergency Hospital | Rostov-on-Don | 344029 | Russia |
| Mechnikov North-Western State Medical University | Saint Petersburg | 191015 | Russia |
| Medical Center Sanavita | Saint Petersburg | 197341 | Russia |
| Tomsk Regional Clinical Hospital | Tomsk | 634063 | Russia |
| Hospital Universitario de Cruces | Barakaldo | Basque Country | 48903 | Spain |
| Hospital Galdakao-Usansolo | Galdakao | 48960 | Spain |
| Hospital Universitario Insular de Gran Canaria | Gran Canaria | 35016 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital de Merida | Mérida | 06800 | Spain |
| Royal Berkshire Hospital | Derby | DE1 2QY | United Kingdom |
| Eastbourne District General Hospital | Eastbourne | BN21 2UD | United Kingdom |
| Western General Hospital | Edinburgh Scotland | EH4 2XU | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Luton and Dunstable University Hosptial | Luton | LU4 0DZ | United Kingdom |
| Torbay Hospital | Torquay South Devon | TQ12 3JX | United Kingdom |
| Royal Cornwall Hospitals Trust | Truro | TR1 3LJ | United Kingdom |
| Wolverhampton Road | Wolverhampton | WV10 0QP | United Kingdom |
| Derived |
| Coates LC, Gladman DD, Merola JF, Mrowietz U, Armstrong A, Baraliakos X, Tillett W, Kishimoto M, Reddy J, Teng L, Amouzadeh H, Deignan C, Mease PJ, Gossec L. Progression from oligoarticular to polyarticular psoriatic arthritis and apremilast as a disease modifier: novel insights from FOREMOST. Rheumatology (Oxford). 2026 Jul 1:keag351. doi: 10.1093/rheumatology/keag351. Online ahead of print. |
| Placebo-controlled Phase: Apremilast 30 mg |
Participants were randomized to receive apremilast 30 mg BID from day 1. Participants could also have received stable doses of NSAIDs and 1 csDMARD. |
| FG002 | Apremilast-extension Phase: Placebo Then Apremilast 30 mg | Participants were randomized to receive placebo in the placebo-controlled phase, and entered the open-label apremilast-extension phase to receive apremilast 30 mg BID from week 24 to week 48. |
| FG003 | Apremilast-extension Phase: Continued Apremilast 30 mg | Participants were randomized to receive apremilast 30 mg BID in the placebo-controlled phase, and entered the open-label apremilast-extension phase to continue on apremilast 30 mg BID from week 24 to week 48. |
| Full Analysis Set |
|
| Safety Analysis Set | Included participants according to the treatment they actually received. |
|
| Escaped Early at Week 16 |
|
| Completed Week 16 and Continued |
|
| COMPLETED | Completed to Week 24 and continued to extension phase |
|
| NOT COMPLETED |
|
|
| Apremilast Extension (Weeks 24 - 48) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-controlled Phase: Placebo | Participants were randomized to receive placebo BID from day 1. Participants could also have received stable doses of NSAIDs and 1 csDMARD. |
| BG001 | Placebo-controlled Phase: Apremilast 30 mg | Participants were randomized to receive apremilast 30 mg BID from day 1. Participants could also have received stable doses of NSAIDs and 1 csDMARD. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Clinical State of Minimal Disease Activity (MDA-Joints) Response at Week 16 | MDA is defined as tender joint counts (TJC) ≤ 1 and SJC ≤ 1 plus 3 of the following 5 criteria:
| The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
|
|
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| Secondary | Percentage of Participants Who Achieved Remission or Low Disease Activity at Week 16 Based on Clinical Activity in Psoriatic Arthritis (cDAPSA) | The cDAPSA score is based on the numerical summation of 4 disease activity variables: tender and swollen joints, patient's global assessments of disease activity and assessment of pain (VAS). The cDAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. cDAPSA remission is defined as a DAPSA score ≤ 4 and low disease activity is defined as a cDAPSA score > 4 but ≤ 13). | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With SJC ≤ 1 at Week 16 | The SJC was based on 66 joints and at week 16 is based on the sentinel joints (i.e., the joints that were affected at baseline). A SJC response is defined as a count ≤ 1. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TJC ≤ 1 at Week 16 | The TJC was based on 68 joints and at week 16 was based on the sentinel joints (i.e., the joints that were affected at baseline). A TJC response is defined as a count ≤ 1. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Patient's Global Assessments of Disease Activity Score of ≤ 20 mm in the VAS at Week 16 | The Patient's Global Assessments of Disease Activity is an assessment of how active a participant's psoriatic arthritis was on average during the last week. It was assessed on a VAS ranging from 0 to 100 mm, with a higher score indicating more disease activity. A response is defined as a score ≤ 20 mm. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Assessment of Pain Score ≤ 15 mm in VAS at Week 16 | The Patients Pain VAS is the participant's assessment of how much pain they had, on average, during the last week in their joints due to psoriatic arthritis. The VAS score ranges from 0 to 100 mm, with a higher score indicating more pain. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Week 16 |
|
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| Secondary | Change From Baseline in Psoriatic Arthritis Impact of Disease 12-item for Clinical Trials (PsAID-12) Questionnaire Score at Week 16 | The PsAID-12 Questionnaire is a 12-item, self-administered questionnaire that reflects the impact of psoriatic arthritis from the perspective of the participant. The overall score ranges from 0 (best status) to 10 (worst status), with a cut-off ≤ 4 representing patient-acceptable symptom state. Analysis was based on a mixed-effects model for repeated measures (MMRM), which included treatment group, time, treatment group by time interaction, prior/concomitant use of csDMARD (naive, prior use only, both prior and concomitant use) and baseline glucocorticosteroid use (yes/no) per IWRS data as factors, and baseline value as a covariate. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Week 16 |
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| Secondary | Percentage of Participants With a Good or Moderate Psoriatic Arthritis Disease Activity (PASDAS) Score at Week 16 | The PASDAS is a weighted index comprising assessments of joints, function, acute-phase response, quality of life, and patient and physician VAS. The score range of the PASDAS is 0 - 10, with worse disease activity represented by higher scores. A good response is defined as a PASDAS score of ≤ 3.2 with improvement from baseline ≥ 1.6 points. A moderate response is defined as a PASDAS score > 3.2 with improvement from baseline ≥ 1.6 points; or PASDAS score < 5.4 with improvement from baseline ≥ 0.8 but < 1.6 points. | The full analysis set included all participants who were randomized as specified in the protocol. | Posted | Number | percentage of participants | Baseline and Week 16 |
|
Week 0 up to week 48 (end of extension phase), and a 4-week observational follow-up (up to 52 weeks).
The safety analysis set included all participants who received at least 1 dose of study medication. For the placebo-controlled phase, participants were included in the treatment group for the treatment they actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo-controlled Phase: Placebo | Participants were randomized to receive placebo BID from day 1. Participants could also have received stable doses of NSAIDs and 1 csDMARD. | 0 | 104 | 6 | 104 | 18 | 104 |
| EG001 | Placebo-controlled Phase: Apremilast 30 mg | Participants were randomized to receive apremilast 30 mg BID from day 1. Participants could also have received stable doses of NSAIDs and 1 csDMARD. | 2 | 204 | 9 | 204 | 72 | 204 |
| EG002 | Apremilast-exposure: Apremilast 30 mg During Placebo-controlled and Extension Phases | All participants who received apremilast 30 mg BID during the study, including: participants who were randomized to placebo during the placebo-controlled phase, and received apremilast 30 mg during the extension phase; and all participants who received apremilast 30 mg BID during the placebo-controlled phase. | 2 | 291 | 15 | 291 | 103 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2023 | Dec 14, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Not Collected or Unknown |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Superiority |
| Participants |
|
|
|
|
|
|
|
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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