Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C0524T08 | Other Identifier | Centocor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray related to joint damage, psoriasis skin lesions, physical function, and quality of life.
Anti-tumor necrosis factor (TNF) agents have been shown to be effective in improving arthritis and psoriasis symptoms in patients with active psoriatic arthritis. Golimumab is a new anti-TNFa agent. This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled, parallel group study comparing safety and efficacy of golimumab 50mg, golimumab 100mg, and placebo subcutaneous injections administered every 4 weeks, in subjects with active PsA. The total duration of treatment is approximately 5 years. In the first portion of the study, some patients will be randomly assigned to receive placebo treatment through the Week 20 injection; others will be assigned to golimumab 50mg or golimumab 100mg groups through the Week 20 injection. There is an "early escape" at Week 16 in the study whereby patients who meet criteria for minimal improvement in their joints will be switched to golimumab if they were on placebo, or have the golimumab dose increased if they were originally assigned to the golimumab 50mg group. At Week 24, the placebo group subjects will switch to golimumab 50mg injections, and all patients will continue receiving in a blinded manner either 50 or 100mg golimumab injections every 4 weeks until the first 52 weeks of data are fully collected on all the subjects (database lock). After this 52-week database lock, everyone will be unblinded to the golimumab dose, and continue to receive golimumab treatment through Week 252 as part of a long-term extension phase of the study, with options for adjusting concomitant PsA medications and/or increasing the dose of golimumab. The study hypothesis is that golimumab will be more effective than placebo both in terms of reducing the signs and symptoms of PsA, as measured by the American College of Rheumatology (ACR) 20 response at Week 14, and inhibiting the amount of damage due to PsA seen on x-rays of the hand and feet at Week 24, while maintaining an acceptable safety profile. Golimumab 50mg, Golimumab 100mg, or placebo injected under the skin every 4 weeks at Weeks 0, 4, 8, 12, 16, and 20, followed by injections of either Golimumab 50mg or Golimumab 100mg every 4 weeks, for approximately 5 years total duration from the time of the first study agent injection.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 002 | Experimental | golimumab 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg |
|
| 001 | Experimental | Placebo; golimumab SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg |
|
| 003 | Experimental | golimumab 100 mg sc injections every 4 wks from wk 0 up to 5 yrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| golimumab | Biological | 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology (ACR) 20 Response at Week 14 | ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP]) | Baseline (Week 0), Week 4, Week 8 and Week 14 |
| Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24 | Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline | Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30412238 | Derived | Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309. | |
| 27803138 | Derived | Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1. |
Not provided
Not provided
Not provided
405 patients were randomized at 57 centers: 35 in North America (17 in the United States and 18 in Canada) and 22 in Europe (5 in Belgium, 10 in Poland, 3 in Spain, and 4 in the United Kingdom). The first patient was enrolled on 12 Dec 2005. The date of the last patient visit for the week (Wk) 24 reporting period was 14 May 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Placebo | Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo; golimumab | Biological | SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg |
|
| golimumab | Biological | 100 mg sc injections every 4 wks from wk 0 up to 5 yrs |
|
| Baseline, Week 4, Week 8 and Week 14 |
| Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24 | Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores. | Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24 |
| Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14 | The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100. | Baseline and Week 14 |
| American College of Rheumatology 20 at Week 24 | Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP]) | Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24 |
| La Jolla |
| California |
| United States |
| Upland | California | United States |
| Aventura | Florida | United States |
| Coeur d'Alene | Idaho | United States |
| Kansas City | Kansas | United States |
| Wheaton | Maryland | United States |
| Worcester | Massachusetts | United States |
| Omaha | Nebraska | United States |
| Cincinnati | Ohio | United States |
| Mayfield | Ohio | United States |
| Lake Oswego | Oregon | United States |
| Portland | Oregon | United States |
| Duncansville | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Houston | Texas | United States |
| Edmonds | Washington | United States |
| Seattle | Washington | United States |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Merksem | Belgium |
| Victoria | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| North Bay | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Waterloo | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Sante Foy | Quebec | Canada |
| Claire | Canada |
| Hamilton Ontario | Canada |
| Newmarket | Canada |
| Saskatoon | Canada |
| Vancouver | Canada |
| Bialystok | Poland |
| Elblag | Poland |
| Kalisz | Poland |
| Poznan | Poland |
| Szczecin | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Santiago de Compostela | Spain |
| Valencia | Spain |
| Glasgow | United Kingdom |
| London | United Kingdom |
| Middlesbrough | United Kingdom |
| Wigan | United Kingdom |
| 27457512 | Derived | Aletaha D, Alasti F, Smolen JS. Disease activity states of the DAPSA, a psoriatic arthritis specific instrument, are valid against functional status and structural progression. Ann Rheum Dis. 2017 Feb;76(2):418-421. doi: 10.1136/annrheumdis-2016-209511. Epub 2016 Jul 25. |
| 25779603 | Derived | Kavanaugh A, van der Heijde D, Beutler A, Gladman D, Mease P, Krueger GG, McInnes IB, Helliwell P, Coates LC, Xu S. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2016 Feb;68(2):267-74. doi: 10.1002/acr.22576. |
| 24748630 | Derived | Kavanaugh A, McInnes IB, Mease P, Krueger GG, Gladman D, van der Heijde D, Zhou Y, Lu J, Leu JH, Goldstein N, Beutler A. Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study). Ann Rheum Dis. 2014 Sep;73(9):1689-94. doi: 10.1136/annrheumdis-2013-204902. Epub 2014 Apr 19. |
| 24127416 | Derived | Helliwell PS, Kavanaugh A. Comparison of composite measures of disease activity in psoriatic arthritis using data from an interventional study with golimumab. Arthritis Care Res (Hoboken). 2014 May;66(5):749-56. doi: 10.1002/acr.22204. |
| 23666608 | Derived | Kavanaugh A, McInnes IB, Krueger GG, Gladman D, Beutler A, Gathany T, Mack M, Tandon N, Han C, Mease P. Patient-reported outcomes and the association with clinical response in patients with active psoriatic arthritis treated with golimumab: findings through 2 years of a phase III, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1666-73. doi: 10.1002/acr.22044. |
| 22378566 | Derived | Kavanaugh A, van der Heijde D, McInnes IB, Mease P, Krueger GG, Gladman DD, Gomez-Reino J, Papp K, Baratelle A, Xu W, Mudivarthy S, Mack M, Rahman MU, Xu Z, Zrubek J, Beutler A. Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis Rheum. 2012 Aug;64(8):2504-17. doi: 10.1002/art.34436. |
| FG001 | Group 2: Golimumab 50 mg | Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. |
| FG002 | Group 3: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Placebo | Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. |
| BG001 | Group 2: Golimumab 50 mg | Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. |
| BG002 | Group 3: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs. |
| 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 | American College of Rheumatology (ACR) 20 Response at Week 14 | ACR 20 response is an improvement of >= 20% from baseline (baseline measurement is defined as the closest measurement taken prior to or at the time of the initiation of study medication administration) in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP]) | Intention to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders. | Posted | Number | Participants | Baseline (Week 0), Week 4, Week 8 and Week 14 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Psoriasis Area and Severity Index (PASI) 75 Response at Week 14 in a Subset of Patients With ≥ 3 Percent Body Surface Area (BSA) Psoriasis Skin Involvement at Baseline | Number of patients (randomized patients with >= 3 percent Body Surface Area [BSA] psoriasis skin involvement at baseline) with Psoriasis Area and Severity Index (PASI) 75 response at Week 14. PASI is the widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 to 72. Zero (0) means no disease and 72 means maximal disease. PASI 75 Response at Week 14 means reduction in PASI score by 75 percent at Week 14. | In a subset of patients with ≥ 3 percent body surface area (BSA) psoriasis skin involvement at baseline. Missing scores were imputed by Last Observation Carried Forward (LOCF). | Posted | Number | Participants | Baseline, Week 4, Week 8 and Week 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Improvement From Baseline in Health Assessment Questionnaire Scores at Week 24 | Summary of improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores. | Intention to treat (ITT). Missing scores were imputed by LOCF. Week (Wk) 16 scores were used for patients with change in study treatment. Week 16 HAQ scores were used for patients with change in study treatment. | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Physical Component Summary Score of the 36-item Short Form Health Survey at Week 14 | The short form health survey (SF-36) is a well-validated and widely used quality-of-life instrument employed in numerous disease states. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100. | Intention to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 14 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Total Radiographic Scores of the Hands and Feet at Week 24 | Summary of change from baseline in total van der Heijde-Sharp (vdH-S) score of the hands and feet, as modified for psoriatic arthritis, at Week 24. The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 to 528 with higher scores indicating more joint damage. For the change from baseline, positive values show an increase in damage. | Intent-to-treat analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 20 at Week 24 | Number of Patients who achieved an American College of Rheumatology (ACR) 20 response at Week (Wk) 24. ACR 20 response is an improvement of >= 20% from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity Visual Analogue Scale [VAS], Health Assessment Questionnaire [HAQ] and C-reactive protein [CRP]) | ITT. Patients considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. Wk 16 ACR response was used for patients with change in study treatment. | Posted | Number | P a r t i c ip an t s | Baseline, Week 4, Week 8, Week 14, Week 16, Week 20 and Week 24 |
|
Not provided
The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in 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 | Group 1: Golimumab 50 mg | Subjects who were treated with Golimumab and received Golimumab 50 mg injections only. | 29 | 139 | 107 | 139 | ||
| EG001 | Group 2: Golimumab 100 mg | Subjects who were treated with Golimumab and received Golimumab 100 mg injections only. | 25 | 109 | 91 | 109 | ||
| EG002 | Group 3: Golimumab 50 and 100 mg | Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg. | 29 | 146 | 113 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Erosive Oesophagitis | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oesophageal Pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Accidental Death | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arthritis Bacterial | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bartholin's Abscess | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Eye Infection Toxoplasmal | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Histoplasmosis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pneumonia Legionella | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Delayed Recovery from Anaesthesia | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tendon Injury | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma Stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Colon Cancer Stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oesophageal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Renal Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Small Cell Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cervical Myelopathy | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Renal Colic | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Thrombophlebitis Superficial | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Centocor Research and Development, Inc. | 1-800-457-6399 |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D025241 | Spondylarthritis |
| D025242 | Spondylarthropathies |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage). | <0.001 | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage). | <0.001 | 95 | No | Superiority or Other |
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
| OG002 | Group III: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs. |
| OG003 | Combined: Group II & III | Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg). |
|
|
|
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg. |
| OG002 | Group III: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs. |
| OG003 | Combined: Group II & III | Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg). |
|
|
|
| OG002 | Group III: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs. |
| OG003 | Combined: Group II & III | Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg). |
|
|
|
| OG002 | Group III: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs. |
| OG003 | Combined: Group II & III | Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg). |
|
|
|
Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
| OG002 | Group III: Golimumab 100 mg | Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs. |
| OG003 | Combined: Group II & III | Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg). |
|
|
|