| Primary | Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score | Percentage of participants with clinical remission at Week 6 as assessed by the Mayo score was reported. Clinical remission was defined as a Mayo score of less than or equal to (<=) 2 point, with no individual sub-score greater than (>) 1. The Mayo score was sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the induction phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Percentage of Participants With Symptomatic Remission at Week 54 | Percentage of participants with symptomatic remission at Week 54 was reported. Symptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. | Full golimumab analysis set 2 (FGAS2) included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Mayo Score | Percentage of participants with clinical remission at Week 54 was reported. Clinical remission was defined as a Mayo score <= 2 points, with no individual subscore >1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS2 included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score | Percentage of participants with clinical remission at Week 54 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score <10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only [in less than 50 percent (%) of stools] =10, small amount with most stools =20, large amount [>50% of the stool content] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, >8 =15); nocturnal bowel movement (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity. | FGAS2 included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score | Percentage of participants with clinical remission at Week 6 as assessed by PUCAI score was reported. Clinical remission as measured by the PUCAI score was a PUCAI score <10. PUCAI score was intended for pediatric participants with UC. PUCAI consisted of the following 6 subscores with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only [in less than 50% of stools] =10, small amount with most stools =20, large amount [>50% of the stool content] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, >8 =15); nocturnal bowel movement (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity. | FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the Short-Term Phase (Weeks 0-6). This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Clinical Response at Week 6 as Assessed by the Mayo Score | Clinical response was defined as a decrease from baseline in the Mayo score by >= 30% and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the Short-Term Phase (Weeks 0-6). This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Endoscopic Healing at Week 6 as Assessed by the Mayo Score | Percentage of participants with endoscopic healing at Week 6 as assessed by the Mayo score was reported. Endoscopic healing was defined by an endoscopy subscore of the Mayo score of 0 or 1 based on local endoscopy. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each subscore rated on a scale from 0 (normal) to 3 (severe), with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS1 included all enrolled participants who received at least 1 dose (complete or partial) of golimumab during the Short-Term Phase (Weeks 0-6). This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Endoscopic Healing at Week 54 as Assessed by the Mayo Score | Percentage of participants with endoscopic healing at Week 54 as assessed by the Mayo score was reported. Endoscopic healing is defined as an endoscopy subscore of the Mayo score of 0 or 1 based on local endoscopy. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each subscore rated on a scale from 0 (normal) to 3 (severe), with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS2 included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be analyzed for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants With Clinical Remission at Week 54 as Assessed by the Mayo Score for Participants Who Were in Clinical Remission at Week 6 | Percentage of participants with clinical remission at Week 54 as assessed by the Mayo score for participants who were in clinical remission at week 6 was reported. Clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | Analysis population included participants who had achieved clinical remission at Week 6. This outcome measure was planned to be reported for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|
| Secondary | Percentage of Participants Who Were Not Receiving Corticosteroids for at Least 12 Weeks Prior to Week 54 and in Clinical Remission at Week 54 | Percentage of participants who were not receiving corticosteroids for at least 12 weeks prior to Week 54 and in clinical remission at week 54 was reported. Clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score was the sum of 4 sub-scores (that is, stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total score was calculated as the sum of the 4 sub scores and values ranged from 0 to 12. A score of 3 to 5 points indicated mildly active disease; a score of 6 to 10 indicated moderately active disease; and a score of 11 to 12 indicated severe disease. | FGAS2 included participants who were in clinical response at Week 6 to golimumab as assessed by the Mayo score (local reader) and who received at least 1 dose (complete or partial) of golimumab during the long-term phase. This outcome measure was planned to be analyzed for "Group 1: Golimumab" arm only. | Posted | | Number | 90% Confidence Interval | Percentage of participants | | Week 54 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Golimumab | In short term phase (Week 0-6), participants weighing greater than or equal to (>=) 45 kilograms (kg), received fixed subcutaneous induction doses of golimumab 200 milligrams (mg) at Week 0 and 100 mg at Week 2. Participants weighing less than (<) 45 kg received body surface area (BSA) adjusted doses with 120 milligrams per square meter (mg/m^2) (up to a maximum of 200 mg) at Week 0 and 60 mg/m^2 (up to a maximum of 100 mg) at Week 2. In long-term Phase (Week 6 through Week 54), participants who showed a clinical response at Week 6 continued receiving subcutaneous golimumab 100 mg or 60 mg/m^2 every 4 weeks (q4w) through Week 50. Participants with no clinical response (non-responders) at Week 6 received additional golimumab doses at Weeks 6 and 10 at the discretion of the investigator. Participants who showed partial Mayo response at Week 14, continued golimumab 100 mg or 60 mg/m^2 qw4 through Week 50. Participants without a partial Mayo response at Week 14 were withdrawn from further treatment and entered a 16-week safety follow-up period after the last dose. In study extension (Week 54 to end of study) phase, participants who were benefited from golimumab, at the discretion of the investigator, continued to receive SC golimumab q4w until marketing authorization is obtained for golimumab or participant turns 18 years had access to commercially available golimumab or decided by the sponsor. |
|