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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000859-14 | EudraCT Number |
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This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy, study of the efficacy and safety of apremilast, etanercept, and placebo, in adults with moderate to severe plaque psoriasis.
250 participants will be randomized 1:1:1 to the three treatment groups. All subjects will receive both tablets and injections through Week 16.
The study will consist of four phases:
During the double-blind, placebo-controlled phase, subjects will receive treatment with one of the following:
All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up Phase either upon completion of the study or upon discontinuation of investigational product for those subjects who terminate the study early.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast 30 mg plus placebo injection | Experimental | Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections |
|
| Etanercept 50 mg plus placebo tablet | Experimental | Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID |
|
| Oral placebo tablets plus SC placebo injections | Placebo Comparator | Identically matching placebo tablets and evaluator/subject-blinded SC injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Apremilast 30 mg tablet orally BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline | PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16 | PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. |
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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 Research Center | Phoenix | Arizona | 85023 | United States | ||
| Bakersfield Dermatology and Skin Cancer Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34255891 | Background | Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23. | |
| 37316690 |
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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 were randomized 1:1:1 to the three treatment groups. Participants were stratified according to their calculated body mass index (BMI) categories at Screening (BMI < 30 or BMI ≥ 30).
The study was conducted at 65 study centers in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| FG001 | Apremilast Plus Placebo Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-controlled Phase (Weeks 0-16) |
|
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| Etanercept | Drug | Etanercept 50 mg evaluator/subject-blinded SC QW injection |
|
|
| Placebo tablet | Drug | Placebo tablets BID |
|
| Placebo injection | Drug | Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC) |
|
| Baseline and Week 16 |
| Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score. | Baseline and Week 16 |
| Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA. | Baseline to Week 16 |
| Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. | Baseline to Week 16 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | Baseline to Week 16 |
| Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value. | Baseline to Week 16 |
| Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least. | Baseline to Week 16 |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase | A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. | Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period | A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above. | From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose |
| Psoriasis Flare/Rebound | Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. | Week 0 to Week 16; Placebo controlled phase |
| Psoriasis Flare/Rebound | Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase. | From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast. |
| Bakersfield |
| California |
| 93309 |
| United States |
| University of California Irvine-Department of Dermatology | Irvine | California | 92697 | United States |
| University of California San Diego Medical Center | San Diego | California | 92122 | United States |
| Horizons Clinical Research | Denver | Colorado | 80220 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Florida Center for Dermatology, PA | Jacksonville | Florida | 32204 | United States |
| Florida Academic Dermatology Center | Miami | Florida | 33136 | United States |
| International Dermatology Research | Miami | Florida | 33144 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Atlanta Dermatology, Vein and Research Center, PC | Alpharetta | Georgia | 30022 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Dermatology and Advanced Aesthetics | Lake Charles | Louisiana | 70605 | United States |
| Lawrence Green, MD, LLC | Rockville | Maryland | 20850 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Robert Wood Johnson Medical School | Somerset | New Jersey | 08873 | United States |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | United States |
| NYU Department of Dermatology | New York | New York | 10016 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27516 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43230 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Tennesse Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Teckton Research | Austin | Texas | 78745 | United States |
| The Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research Inc | Norfolk | Virginia | 23507 | United States |
| Dermatology Associates of Seattle | Seattle | Washington | 98101 | United States |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Fremantle Dermatology | Fremantle | Western Australia | 6160 | Australia |
| Gairdner Hospital | Victoria Park | 6100 | Australia |
| Rheumatology unit Ward 5C Queen Elizabeth Hospital | Woodville | 5011 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| University Hospital of Liege CHU Liege | Liège | 4000 | Belgium |
| Eastern Canada Cutaneous Research Associates Ltd | Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Skin Center for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| K. Papp Clinical Research Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| Siena Medical Research | Montreal | Quebec | H3Z 2S6 | Canada |
| Q & T Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Dorothea, Kožnà a korektivne dermatologické pracovište | Chomutov | 430 04 | Czechia |
| Dermamedica | Náchod | 54701 | Czechia |
| Východoceské dermatologické centrum Homea s.r.o. | Pardubice | 530 02 | Czechia |
| Krajská nemocnice Pardubice, Kožnà oddelenà | Pardubice | 532 03 | Czechia |
| Dermatovenerologicka ambulance | Svitavy | 568 02 | Czechia |
| Koznia zilni ambulance | Ústà nad Labem | 400 10 | Czechia |
| South Estonian Hospital Ltd | Meegomäe Village, Võru County | 65526 | Estonia |
| Dermatology Clinic of Tartu University Hospital | Tartu | 50417 | Estonia |
| Psoriasis Study Center | Berlin | 10117 | Germany |
| Dermatologische Praxis | Berlin | 10827 | Germany |
| Klinische Forschung Berlin - Buch GmbH | Berlin | 13125 | Germany |
| University Hospital Carl Gustav Carus | Dresden | 1307 | Germany |
| Hautklinik Universitatsklinikum Erlangen | Erlangen | 91054 | Germany |
| University Hospital Frankfurt | Frankfurt | 60590 | Germany |
| SCIderm GmbH | Hamburg | 20354 | Germany |
| Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center | Hamburg | D-20246 | Germany |
| Universitatsklinikum Heidelberg | Heidelberg | 69115 | Germany |
| UniversitatsKlinikum Leipzig A.o.R. | Leipzig | 4103 | Germany |
| Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein | Lübeck | 23538 | Germany |
| Gemeinschaftspraxis Mahlow | Mahlow | 15831 | Germany |
| University Hospital Munster | Münster | 48143 | Germany |
| Praxis fr Dermatologie und Venerologie | Wuppertal | 42275 | Germany |
| Tolna Megyei Balassa Janos Korhaz | Szekszárd | 7100 | Hungary |
| Allergo-Derm Bakos Kft. | Szolnok | 5000 | Hungary |
| LTD M & M centrs | Adazi | 2164 | Latvia |
| Arija's Ancane's Family Doctor Private Practice | Baldone | 2125 | Latvia |
| Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre | Riga | 1001 | Latvia |
| Adoria Ltd | Riga | 1011 | Latvia |
| Family Doctor's Indra's Kenina's Practice | Riga | 1011 | Latvia |
| Health Center of Talsi Ltd | Talsi | 3201 | Latvia |
| Academic Medical Center | Amsterdam | 1105 AZ | Netherlands |
| Radboud University Medical Centre | Nijmegen | 6500HB | Netherlands |
| University Hospital of Wales | Cardiff | CF14 4XN | United Kingdom |
| Leeds Teaching Hospitals Trust | Leeds | LS7 4SA | United Kingdom |
| Whipps Cross University Hospital | London | E11 1NR | United Kingdom |
| St Helier Hospital | London | SM5 1AA | United Kingdom |
| George Eliot Hospital | Nuneaton | CV10 7DJ | United Kingdom |
| Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14. |
| 27768242 | Derived | Reich K, Gooderham M, Green L, Bewley A, Zhang Z, Khanskaya I, Day RM, Goncalves J, Shah K, Piguet V, Soung J. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017 Mar;31(3):507-517. doi: 10.1111/jdv.14015. Epub 2016 Dec 19. |
Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
| FG002 | Etanercept Plus Placebo Tablet | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| FG003 | Placebo/Apremilast | Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104. |
| FG004 | Apremilast/Apremilast | Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104. |
| FG005 | Etanercept/Apremilast | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104. |
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Apremilast Extension Phase (Weeks16-104) |
|
|
Randomized population includes all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| BG001 | Apremilast Plus Placebo Injection | Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| BG002 | Etanercept Plus Placebo Tablet | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| BG003 | 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 |
|
| 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 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline | PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. | The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF). | Posted | Number | Percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16 | PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. | mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline and Week 16 |
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| Secondary | Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline to Week 16 |
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| Secondary | Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF). | Posted | Number | percentage of participants | Baseline to Week 16 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to Week 16 |
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| Secondary | Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to Week 16 |
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| Secondary | Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16 | The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least. | mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF. | Posted | Number | percentage of participants | Baseline to Week 16 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase | A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. | Safety population includes all participants who were randomized and received at least one dose of study drug. | Posted | Number | participants | Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period | A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above. | All participants who received apremilast at any time during the study. | Posted | Number | participants | From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose |
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| Secondary | Psoriasis Flare/Rebound | Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. | Safety population includes all participants who were randomized and received at least one dose of study drug. | Posted | Number | participants | Week 0 to Week 16; Placebo controlled phase |
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| Secondary | Psoriasis Flare/Rebound | Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase. | Safety population includes all participants who were randomized and received at least one dose of study drug. | Posted | Number | participants | From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast. |
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Adverse events are reported for the 16-week placebo-controlled period and up to week 104 during the apremilast exposure period for all participants who were randomized or switched to apremilast at any time during the course of the study.
The mean duration of exposure was 14.90 weeks, 15.13 weeks, and 15.87 weeks for participants randomized to the placebo, apremilast 30 BID, and etanercept 50 mg every week treatment groups, respectively during the placebo controlled phase. The mean duration of exposure to apremilast 30 mg BID during the apremilast exposure period was 69.13 weeks.
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 (Week 0-16) | Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase | 0 | 84 | 25 | 84 | ||
| EG001 | Apremilast Plus Placebo Injection (Week 0-16) | Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase | 3 | 83 | 41 | 83 | ||
| EG002 | Etanercept Plus Placebo Tablets (Week 0-16) | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase | 2 | 83 | 27 | 83 | ||
| EG003 | Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104 | Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104. | 5 | 73 | 30 | 73 | ||
| EG004 | APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104 | Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104. | 6 | 83 | 52 | 83 | ||
| EG005 | Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104 | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104. | 4 | 79 | 32 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Anogenital warts | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumocephalus | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tension Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rebound psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 12 months since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Manager, Clinical Trial Disclosure | Celgene Corporation | 888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
Not provided
Not provided
| Lack of Efficacy |
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| Non-compliance With Study Drug |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Male |
|
| OG001 |
| Etanercept 50mg Plus Placebo Tablet |
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase. |
|
|
|
Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| OG002 | Etanercept Plus Placebo Tablet | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase. |
|
|
|
| Etanercept Plus Placebo Tablets |
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
|
| Apremilast Plus Placebo Injection |
Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| OG002 | Etanercept Plus Placebo Tablet | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
|
| OG001 | Apremilast 30mg Plus Placebo Injection | Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| OG002 | Etanercept 50mg Plus Placebo Tablet | Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
|
| OG001 | Apremilast Plus Placebo Injection | Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| OG002 | Etanercept Plus Placebo Tablets | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
|
| OG002 | Etanercept Plus Placebo Tablets | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
|
| Apremilast Plus Placebo Injection |
Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
| OG002 | Etanercept Plus Placebo Tablets | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase |
|
|
| OG001 | Apremilast/Apremilast | Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104. |
| OG002 | Etanercept/Apremilast | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104. |
|
|
Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
|
|
Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
| OG002 | Etanercept/Apremilast | Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104. |
|
|