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| ID | Type | Description | Link |
|---|---|---|---|
| C0524T02 | Other Identifier | Centocor |
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| Name | Class |
|---|---|
| Centocor BV | INDUSTRY |
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Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab (CNTO 148) with Methotrexate (MTX) | Experimental |
| |
| Infliximab with MTX | Experimental |
| |
| Placebo with MTX | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 | ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of ACR-N, Index of Improvement at Week 16 | The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18383539 | Derived | Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383. |
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A total of 172 participants were randomly assigned to treatments at 33 sites: 16 in North America (13 in the US and 3 in Canada), 12 in Europe (3 in Belgium, 4 in the UK, 5 in Germany), and 5 in Australia. The study period extended from 01 Dec 2003 to 21 Feb 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Placebo Crossover to Infliximab | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. |
| FG001 | Group II: Golimumab 50 mg Every 4 Weeks | Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. |
| FG002 | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. |
| FG003 | Group IV: Golibumab 100 mg Every 4 Weeks | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. |
| FG004 | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Placebo Crossover to Infliximab | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 | ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]). | Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders. | Posted | Number | Participants | Week 16 |
|
Baseline to Week 52
Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I: Placebo Crossover to Infliximab | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research | Centocor Research & Development, Inc. | 1-800-457-6399 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D018771 | Arthralgia |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| MTX | Drug | Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous |
|
| Placebo | Drug | Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous |
|
| Infliximab | Drug | Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous |
|
| Week 16 |
| Unsatisfactory therapeutic effect |
|
| Other |
|
| BG001 | Group II: Golimumab 50 mg Every 4 Weeks | Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. |
| BG002 | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. |
| BG003 | Group IV: Golibumab 100 mg Every 4 Weeks | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. |
| BG004 | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Group I: Placebo Crossover to Infliximab |
Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. |
| OG001 | Group II: Golimumab 50 mg Every 4 Weeks | Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. |
| OG002 | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. |
| OG003 | Group IV: Golibumab 100 mg Every 4 Weeks | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. |
| OG004 | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. |
| OG005 | Combined: Groups II, III, IV & V | Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks). |
|
|
|
| Secondary | Summary of ACR-N, Index of Improvement at Week 16 | The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement. | Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied. | Posted | Median | Inter-Quartile Range | Scores on scale | Week 16 |
|
|
|
|
| 2 |
| 34 |
| 28 |
| 34 |
| EG001 | Group II: Golimumab 50 mg Every 4 Weeks | Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. | 7 | 37 | 34 | 37 |
| EG002 | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. | 5 | 32 | 29 | 32 |
| EG003 | Group IV: Golibumab 100 mg Every 4 Weeks | Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. | 5 | 33 | 29 | 33 |
| EG004 | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. | 5 | 35 | 33 | 35 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fracture delayed union | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Listeria sepsis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Fungal rash | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 7.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
Generally, the only disclosure restriction on the Principal Investigator 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| ANOVA on van der Waerden normal scores. |
| 0.006 |
| No |
| Superiority or Other |
| No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks | ANOVA on van der Waerden normal scores. | 0.095 | No | Superiority or Other |
| No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks | ANOVA on van der Waerden normal scores. | ANOVA on van der Waerden normal scores | 0.010 | No | Superiority or Other |
| No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks | ANOVA on van der Waerden normal scores. | <0.001 | No | Superiority or Other |