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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001533-15 | EudraCT Number | ||
| B1801271 | Other Identifier | Alias Study Number |
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The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW). |
|
| B | Active Comparator | Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug |
| ||
| etanercept |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis | The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | The PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital A Posadas | Palomar | Buenos Aires | 1684 | Argentina | ||
| Hospital General de Agudos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30323006 | Derived | Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15. | |
| 25913550 | Derived | Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Subjects were screened up to 4 weeks.
Subjects were recruited worldwide from December 2005 to September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept BIW/QW | Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. |
| FG001 | Etanercept QW/QW |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Double Blind): 1-12 Weeks |
|
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|
| Placebo | Drug |
|
| 12 and 24 weeks |
| Buenos Aires |
| C1001AFA |
| Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | C1001AFA | Argentina |
| CEMIC | Buenos Aires | C1014ADB | Argentina |
| Hospital General de Agudos | Buenos Aires | C1155ADO | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | C1199ABD | Argentina |
| Instituto de Medicina Cutanea | Buenos Aires | C1221ACJ | Argentina |
| Goulburn Street Medical Centre | Liverpool | New South Wales | 2170 | Australia |
| St Vincent's Hospital VIC | Fitzroy | VIC 3065 | Australia |
| Universitaetsklinik Graz | Graz | SM | 8036 | Austria |
| Krankenhaus Rudolfsstiftung | Vienna | 1030 | Austria |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| CHU Liege | Liège | 4000 | Belgium |
| Centro Integral de Reumatologia del Caribe S.A.S | Barranquilla | Atlántico | Colombia |
| Centro Medico de la Sabana | Bogotá | Colombia |
| Centrum Rehabilitace | ZlÃn | Czech Republic | 760 01 | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Revmatologicka Ambulance | Uherské Hradiště | 686 01 | Czechia |
| Bispebjerg University Hospital | Copenhagen | DK-2400 | Denmark |
| Gentofte University Hospital | Hellerup | 2900 | Denmark |
| Hørsholm hospital | Hørsholm | 2970 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| University of Copenhagen - Roskilde Hospital | Roskilde | 4000 | Denmark |
| Mehiläinen Terveyspalvelut Oy Forum | Helsinki | FIN-00100 | Finland |
| Tampereen Reumatoismisto | Tampere | 33100 | Finland |
| Iho ja Allergiapulssi | Turku | 20100 | Finland |
| Centre Hospitalier du Mans | Le Mans | Cedex | 72037 | France |
| Hôpital Saint André | Bordeaux | 33075 | France |
| CHU - Hôpital Morvan | Brest | 29609 | France |
| C.H.R.U. de Caen | Caen | 14000 | France |
| Hôpital Henri Mondor | Créteil | 94000 | France |
| CHU Dupuytren | Limoges | 87042 | France |
| CHU de l Archet | Nice | 06200 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hôpital Bichat - Claude Bernard | Paris | 75018 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| CHU La Milétrie | Poitiers | 86000 | France |
| CHU - Hopital Charles Nicolle | Rouen | 76000 | France |
| CHRU- Hôpital Trousseau | Tours | 37044 | France |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Klinik fuer Dermatologie, Venerologie und Allergologie | Berlin | 10117 | Germany |
| Schonhauser Allee 71 | Berlin | 10437 | Germany |
| Hautarztpraxis Dr. Margrit Simon | Berlin | 10827 | Germany |
| Klinische Forschung Berlin-Buch GmbH | Berlin | 13125 | Germany |
| Schlossparkklinik Berlin | Berlin | 14059 | Germany |
| Klinik und Poliklinik für Dermatologie der Friedrich-Wilhelm | Bonn | 53105 | Germany |
| Allgemeines Krankenhaus Eilbek | Eilbek | 22081 | Germany |
| Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052 | Erlangen | 91052 | Germany |
| Klinikum der J.W. Goethe-Universitat | Frankfurt | 60596 | Germany |
| Georg-August Universitaet Goettingen | Göttingen | D-37075 | Germany |
| SCIderm GmbH Hamburg | Hamburg | 20354 | Germany |
| Friedrich-Schiller Universitat Jena | Jena | 07740 | Germany |
| Friedrich-Schiller Universitat Jena | Jena | 07743 | Germany |
| Bahnhofstr. 1 | Mahlow | 15831 | Germany |
| Klinikum Innenstadt der Universitaet Muenchen | München | 80336 | Germany |
| Klinikum Innenstadt der Universitaet Muenchen | München | 80337 | Germany |
| Dermatologische Gemeinschaftspraxis Rosenbach | Osnabrück | 49078 | Germany |
| Praxis Dr. M. Richter | Rostock | 18059 | Germany |
| Universitaetsklinik Wuerzburg | Würzburg | D-97070 | Germany |
| Universitaetsklinik Wuerzburg | Würzburg | D-97080 | Germany |
| University of Athens Andreas Syngros Hospital Athens, Greece | Athens | 16121 | Greece |
| Semmelweis University - Faculty of Health Sciences | Budapest | 1135 | Hungary |
| Debreceni Egyetem Orvos és Egészségtudományi Centrum | Debrecen | H-4004 | Hungary |
| Miskolc Megyei Jogu Varos Onkormanyzata, Miskolci Egeszsegui | Miskolc | 3529 | Hungary |
| Pecsi Tudomanyegyetem, AOK | Pécs | 7624 | Hungary |
| Medical University of Szeged | Szeged | 6720 | Hungary |
| HETENYI Geza Hospital | Szolnok | 5400 | Hungary |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | 25100 | Italy |
| Ospedale San Giovanni di Dio | Cagliari | 09124 | Italy |
| Clinica Dermatologica | Catania | 95124 | Italy |
| Ospedale Galeazzi | Milan | 20161 | Italy |
| Universita degli Studi di Parma | Parma | 43100 | Italy |
| Policlinico Umberto I - Universita La Sapienza | Roma | 00161 | Italy |
| Idi-Irccs | Roma | Italy |
| Universita degli Studi di Siena | Siena | 53100 | Italy |
| Unidad de Investigacion en | Guadalajara | Jalisco | 44620 | Mexico |
| CLIDITER S.A. de C.V. | Mexico City | 06700 | Mexico |
| University Medical Center St. Radboud | Nijmegen | GA | 6525 | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | THE Netherlands | 6229 HX | Netherlands |
| Ziekenhuis Walcheren | Flushing | 4382 EE | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | 6229 HX | Netherlands |
| Diaconessenhuis Voorburg | Voorburg | 2275 CX | Netherlands |
| Akad. Medyczna im L. Rydygiera | Bydgoszcz | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin | 20-954 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 00-909 | Poland |
| Zesp. Naukowo-Kliniczny IWOLANG, Uzdrowiskowa Klinika Dermat | Warsaw | 00710 | Poland |
| Hospitais Da Universidade De Coimbra | Coimbra | 3000-075 | Portugal |
| Hospital Santo Antonio | Porto | 4050 | Portugal |
| King Faisal Specialist Hospital & Research Centre | Riyadh | 11211 | Saudi Arabia |
| Institute of Rheumatology Belgrade | Belgrade | 11000 | Serbia and Montenegro |
| Institute of Rheumatology Niska Banja | Niska Banja | 18205 | Serbia and Montenegro |
| Clinic for Dermatology and Clinic for Medical Rehabilitation | Novi Sad | 21000 | Serbia and Montenegro |
| Clinical Center Zemun | Zemun | 11080 | Serbia and Montenegro |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Asan Medical Centre | Seoul | 138-736 | South Korea |
| Hospital Universitario Puerto Real | Puerto Real | Cadiz | 11510 | Spain |
| Hospital de Donostia | San Sebastián | Guipúzcua | 20014 | Spain |
| Hospital Insular de Canarias | Las Palmas de Gran Canaria | Isalas Canarias | 35016 | Spain |
| Hospital Severo Ochoa de Leganes | Leganés | Madrid | 28911 | Spain |
| Hospital Nuestra Senora Del Mar | Barcelona | 08003 | Spain |
| Hospital de la Santa Cruz y San Pablo | Barcelona | 08025 | Spain |
| Hospital Ramon y Cajal | Madrid | 28037 | Spain |
| Länssjukhuset Ryhov | Jönköping | 551 85 | Sweden |
| Umeå University Hospital | Umeå | 90185 | Sweden |
| Akademiska Sjukhuset i Uppsala | Uppsala | 751 85 | Sweden |
| CHUV Lausanne | Lausanne | 1011 | Switzerland |
| Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| Chang Gung Memorial Hospital-Kaohsiung | Kaohsiung Hsiang | Taiwan, R.o.c. | 833 | Taiwan |
| National Taiwan University Hospital | Taipei TOC | 100 | Taiwan |
| Hacettepe University Medicine Faculty | Ankara | 06100 | Turkey (Türkiye) |
| The Royal Free Hospital, Pond Street, Hampstead | London | Hampstead | NW3 2QG | United Kingdom |
| Hope Hospital | Salford | Lancashire | M6 8HD | United Kingdom |
| Harrogate District Hospital | Harrogate | North Yorkshire | HG2 7SX | United Kingdom |
| Leeds General Infirmary, Leeds | Leeds | Yorkshire | LS1 3EX | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | AB15 4TN | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| University Hospital of Wales | Cardiff | CF4 4XW | United Kingdom |
| The Royal Free Hospital, Pond Street, Hampstead | London | NW3 2QG | United Kingdom |
| Guy's and St. Thomas' Trust St.Thomas' Hospital | London | SE1 7EH | United Kingdom |
| George Elliott Hospital | Nuneaton | CV10 7DJ | United Kingdom |
| 25535650 | Derived | Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22. |
| 24861696 | Derived | Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13. |
| 22035157 | Derived | Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31. |
| 20124563 | Derived | Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147. |
Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 (Open Label): 13-24 Weeks |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept BIW/QW | Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. |
| BG001 | Etanercept QW/QW | Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. |
| 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 |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | The PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. | The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation. | Posted | Number | participants | 12 and 24 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis | The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1. | The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation. | Posted | Number | participants | 12 weeks |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | Etanercept BIW/QW | Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | 15 | 213 | ||||
| EG001 | Etanercept QW/QW | Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | 11 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment |
| ||
| Abscess | General disorders | Non-systematic Assessment |
| ||
| Accidental injury | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Cerebral ischemia | Vascular disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Vascular disorders | Non-systematic Assessment |
| ||
| Myocardial ischemia | Cardiac disorders | Non-systematic Assessment |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Large intestine perforation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Melena | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomach ulcer hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Abnormal gait | Nervous system disorders | Non-systematic Assessment |
| ||
| Depression | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Chronic obstructive airways disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Kidney pain | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Local reaction to procedure | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
| ||
| Injection site | General disorders | Non-systematic Assessment |
| ||
| Cardiovascular general disorders | Cardiac disorders | Non-systematic Assessment |
| ||
| Digestive general disorders | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Metabolic and nutritional general disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Nervous general disorders | Nervous system disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin and appendages general disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D012871 | Skin Diseases |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| 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
| Unsatisfactory Response |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Withdrawal of consent |
|
| Male |
|
| At 24 Weeks |
|
|
|