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| ID | Type | Description | Link |
|---|---|---|---|
| C0524T28 | Other Identifier | Centocor |
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
Golimumab is a type of tumor necrosis factor (TNF)-inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, a 50% chance to receive golimumab and a 50% chance to receive placebo. If the patient does not have an improvement in their joints at the Week 16 visit compared to when they entered the study, and are in Group 1 (placebo group), the patient will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), the patient will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and is still receiving placebo injections, because there was improvement in their joints at Week 16, the patient will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or is already receiving golimumab injections at week 24, the patient will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (e.g., blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks from randomization (Week 0) until Week 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab + methotrexate (MTX) | Experimental | Participants will receive golimumab 50 mg as subcutaneous (SC) (under the skin) injections administered every 4 weeks for up to 48 weeks. In addition, participants will receive a stable dose of MTX. |
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| Placebo + methotrexate (MTX) | Experimental | Participants will be administered Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. In addition, participants will receive a stable dose of MTX. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | 50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein) | DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of "Good" or "Moderate" at Week 14. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14. |
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Inclusion Criteria:
- Diagnosis of rheumatoid arthritis for at least 6 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
In this trial, 264 participants were randomly assigned to the 2 treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Placebo + MTX -> Golimumab 50 mg + MTX | Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
| FG001 | Group II: Golimumab 50 mg + MTX | Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Placebo + MTX -> Golimumab 50 mg + MTX | Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
| 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 | American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment. | Posted | Number | Number of participants | Week 14 |
|
Up to Week 56
4 patients in Group I received placebo only and are not included in the safety analysis set at Week 56. 1 patient in group 2 did not receive any treatment (see participant flow) and is not included in the safety analysis set at Week 56.
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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 + MTX -> Golimumab 50 mg + MTX | Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research | Janssen Research & Development | 610-500-3369 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug | Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48. |
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| Methotrexate (MTX) | Drug | A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks. |
|
| Week 14 |
| American College of Rheumatology 20 Response, Using CRP, at Week 24 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Week 24 |
| HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline | The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ. | Baseline to Week 24 |
| Chengdu |
| China |
| Hefei | China |
| Jinan | China |
| Nanjing | China |
| Shanghai | China |
| Suzhou | China |
| Wuhan | China |
| Xi'an | China |
| Death |
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| Adverse Event |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Not treated |
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| BG001 | Group II: Golimumab 50 mg + MTX | Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Group II: Golimumab 50 mg + MTX |
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). |
|
|
|
| Secondary | Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein) | DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of "Good" or "Moderate" at Week 14. A "Good" response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A "Moderate" response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14. | Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment. | Posted | Number | Number of participants | Week 14 |
|
|
|
|
| Secondary | American College of Rheumatology 20 Response, Using CRP, at Week 24 | ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity. | Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment. | Posted | Number | Number of participants | Week 24 |
|
|
|
|
| Secondary | HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline | The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ. | Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to Week 24 |
|
|
|
|
| 4 |
| 128 |
| 40 |
| 128 |
| EG001 | Group II: Golimumab 50 mg + MTX | Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week). | 8 | 131 | 35 | 131 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
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| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.1 | Non-systematic Assessment |
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| White Blood Cell Count Decreased | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 14.1 | Non-systematic Assessment |
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| Liver Function Test Abnormal | Investigations | MedDRA Version 14.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA Version 14.1 | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |