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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148ART3002 | Other Identifier | Janssen Biotech Inc. | |
| 2009-010582-23 | EudraCT Number | ||
| GO SAVE | Other Identifier | Janssen Biotech Inc. |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.
The study consists of a main study and a voluntary, open-label (participants and researchers are aware about the treatment participants are receiving), 24-week study extension. The main study includes a Screening Run-in Period (Week -6 to Week 0), an Open-label Treatment Period (Week 0 to Week 16), an Open-label or Double-blind Treatment Period (Week 16 to Week 52). The main study also includes a Follow-up Period from Week 52 through Week 64 for those participants who will not participate in the 24-week study extension. Participants, participating in 24-week extension (at Week 52), will receive open-label golimumab SC injections every 4 weeks from Week 52 up to Week 72 and will be followed-up up to Week 88. All eligible participants will initiate the treatment with open-label golimumab SC injection every 4 weeks up to Week 12. At Week 16, depending upon the treatment response either participants will continue to receive open-label golimumab SC injection every 4 weeks up to Week 48 or participants will be randomly assigned to receive following 2 treatments: 1- golimumab 50mg SC injection every 4 weeks along with placebo intravenous infusion every 8 weeks through Week 48; 2- Placebo SC injection every 4 weeks along with golimumab 2mg/kg intravenous infusion every 8 weeks through Week 48. At Week 52, participants who choose to participate in the 24-week study extension will receive open-label golimumab 50 mg SC injections every 4 weeks through Week 72. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX | Experimental | All enrolled and dosed participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 to Week 12. |
|
| Double blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX | Experimental | Participants, who do not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, will be randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. |
|
| DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX | Experimental | Participants, who do not achieve DAS28 good response at Week 16, will be randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
|
| OL Group 1: Golimumab 50 mg SC + MTX | Experimental | Participants, who achieve DAS28 good response at Week 16, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab 50 mg SC | Drug | Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Biotech, Inc. Clinical Trial | Janssen Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29427176 | Derived | Dehoratius RJ, Brent LH, Curtis JR, Ellis LA, Tang KL. Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. Patient. 2018 Jun;11(3):361-369. doi: 10.1007/s40271-018-0297-5. | |
| 28035867 | Derived | Huffstutter JE, Kafka S, Brent LH, Matucci-Cerinic M, Tang KL, Chevrier M, Sprabery T, DeHoratius RJ. Clinical response to golimumab in rheumatoid arthritis patients who were receiving etanercept or adalimumab: results of a multicenter active treatment study. Curr Med Res Opin. 2017 Apr;33(4):657-666. doi: 10.1080/03007995.2016.1277195. Epub 2017 Jan 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX | All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12. |
| FG001 | OL Group 1: Golimumab 50 mg SC + MTX |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label (OL) Period (Week 0 - 16) |
|
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| OL Study Extension Group: Golimumab 50 mg SC + MTX | Experimental | Participants who complete the main study (Week 0 to Week 52), do not meet lack of efficacy criteria, and participate in the OL study extension, will receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
|
| Golimumab 2 mg/kg IV | Drug | Golimumab 2 milligram per kilogram (mg/kg) intravenous infusion every 8 weeks. |
|
| Methotrexate (MTX) | Drug | Participants will continue taking their current Methotrexate (MTX) treatment regimen. |
|
| Placebo SC | Drug | Placebo matched to golimumab SC injection every 4 weeks. |
|
| Placebo IV | Drug | Placebo matched to golimumab intravenous infusion every 8 weeks. |
|
| Within 2 weeks of initiating therapy |
| Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52 | Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported. | Week 52 |
| Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported. | Week 52 |
| Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16 | Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported. | Week 76 |
| Change in ESR-based DAS28 Score at Week 76 Relative to Week 52 | Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity. | Week 52, 76 |
| Huntsville |
| Alabama |
| United States |
| Tuscaloosa | Alabama | United States |
| Mesa | Arizona | United States |
| Phoenix | Arizona | United States |
| Hot Springs | Arkansas | United States |
| Little Rock | Arkansas | United States |
| Covina | California | United States |
| Hemet | California | United States |
| Loma Linda | California | United States |
| Long Beach | California | United States |
| Murrieta | California | United States |
| Santa Maria | California | United States |
| Santa Monica | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Victorville | California | United States |
| Whittier | California | United States |
| Bridgeport | Connecticut | United States |
| Hamden | Connecticut | United States |
| Trumbull | Connecticut | United States |
| Aventura | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Jacksonville | Florida | United States |
| Naples | Florida | United States |
| Orange Park | Florida | United States |
| Orlando | Florida | United States |
| Palm Harbor | Florida | United States |
| Plantation | Florida | United States |
| Sarasota | Florida | United States |
| Tampa | Florida | United States |
| Duluth | Georgia | United States |
| Coeur d'Alene | Idaho | United States |
| Idaho Falls | Idaho | United States |
| Rockford | Illinois | United States |
| South Bend | Indiana | United States |
| Bettendorf | Iowa | United States |
| Kansas City | Kansas | United States |
| Bowling Green | Kentucky | United States |
| Monroe | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Wheaton | Maryland | United States |
| Rochester | Minnesota | United States |
| Flowood | Mississippi | United States |
| Tupelo | Mississippi | United States |
| Clayton | Missouri | United States |
| Florissant | Missouri | United States |
| Lincoln | Nebraska | United States |
| Freehold | New Jersey | United States |
| Brooklyn | New York | United States |
| Mineola | New York | United States |
| Plainview | New York | United States |
| Rochester | New York | United States |
| Smithtown | New York | United States |
| Charlotte | North Carolina | United States |
| Greenville | North Carolina | United States |
| Hickory | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Akron | Ohio | United States |
| Columbus | Ohio | United States |
| Mayfield | Ohio | United States |
| Middleburg Heights | Ohio | United States |
| Edmond | Oklahoma | United States |
| Oklahoma City | Oklahoma | United States |
| Lake Oswego | Oregon | United States |
| Bethlehem | Pennsylvania | United States |
| Duncansville | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Wexford | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Myrtle Beach | South Carolina | United States |
| Hixson | Tennessee | United States |
| Jackson | Tennessee | United States |
| Kingsport | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Carrollton | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Arlington | Virginia | United States |
| Chesapeake | Virginia | United States |
| Seattle | Washington | United States |
| Spokane | Washington | United States |
| Beckley | West Virginia | United States |
| Clarksburg | West Virginia | United States |
| Glendale | Wisconsin | United States |
| Vienna | Austria |
| Brussels | Belgium |
| Genk | Belgium |
| Ghent | Belgium |
| Liège | Belgium |
| Merksem | Belgium |
| Edmonton | Alberta | Canada |
| Kelowna | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Hamilton | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| St. Johns | Canada |
| Hamburg | Germany |
| Herne | Germany |
| München | Germany |
| Ratingen | Germany |
| Heraklion- Crete | Greece |
| Thessalonikis | Greece |
| Stockholm | Sweden |
| Cannock | United Kingdom |
| Leeds | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Merseyside | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Wigan | United Kingdom |
Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
| FG002 | Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. |
| FG003 | DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
| FG004 | OL Study Extension Group: Golimumab 50 mg SC + MTX | Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
| COMPLETED |
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| NOT COMPLETED |
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|
| OL/Double-Blind (DB) Period (Week 16-52) |
|
|
| OL Study Extension (Week 52 - 76) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OL Overall Group: Golimumab 50 mg SC + MTX | All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. | Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 14 |
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| Secondary | Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. | Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 2 weeks of initiating therapy |
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| Secondary | Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52 | Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported. | Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16 | Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported. | Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16 | Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant's assessment of pain using VAS (0 to 10 cm), 2- Participant's global assessment of disease activity using VAS (0 to 10 cm), 3- Physician's global assessment of disease activity using VAS (0 to 10 cm), 4- Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported. | Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52). | Posted | Number | 95% Confidence Interval | percentage of participants | Week 76 |
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| Secondary | Change in ESR-based DAS28 Score at Week 76 Relative to Week 52 | Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity. | Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of 'Study Extension OL Group' by treatment received in the OL/DB phase (Weeks 16-52). | Posted | Mean | Standard Deviation | units on a scale | Week 52, 76 |
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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 | OL Overall Group: Golimumab 50 mg SC + MTX | All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12. | 20 | 433 | 123 | 433 | ||
| EG001 | OL Group 1: Golimumab 50 mg SC + MTX | Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48. | 2 | 75 | 21 | 75 | ||
| EG002 | Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. | 4 | 91 | 30 | 91 | ||
| EG003 | DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. | 10 | 184 | 54 | 184 | ||
| EG004 | OL Study Extension Group: Golimumab 50 mg SC + MTX | Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. | 10 | 212 | 61 | 212 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Breast cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Essential thrombocythaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
Since participants assigned to the double blind groups were non-responders to at least 2 anti-Tumor Necrosis Factors (TNF), thus comprising a very difficult group to treat.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Janssen Scientific Affairs, LLC | 215-325-4209 | rdehorat@its.jnj.com |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Death |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Canada |
|
| Germany |
|
| Greece |
|
| Italy |
|
| Sweden |
|
| United Kingdom |
|
| United States |
|
|
| Participants |
|
|
Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
|
|
| OG001 |
| DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX |
Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44. |
| OG002 | DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
| OG003 | OL Study Extension Group: Golimumab 50 mg SC + MTX | Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
|
|
| OG002 | DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX | Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48. |
| OG003 | OL Study Extension Group: Golimumab 50 mg SC + MTX | Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72. |
|
|