TriangleNCT00488631 · OUTCOME
Number of Participants With Clinical Remission at Both Week 30 and Week 54
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Week 30 and Week 54
What was measured
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., 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 Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Analysis population: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Groups in this outcome
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
| Group | Source count |
|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 154 |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | 151 |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | 151 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 24 | Not reported | Not reported | Not reported | Not reported |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | 35 | Not reported | Not reported | Not reported | Not reported |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | 42 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.122
- p Value Comment
- Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- group Description
- Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.004
- p Value Comment
- Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Description
- Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.122
- p Value Comment
- Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- group Description
- Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.004
- p Value Comment
- Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 42
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 151
- group Id
- OG002
- value
- 151
- units
- Participants
- description
- Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., 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 Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
- groups
- description
- Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
- id
- OG000
- title
- Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
- description
- Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
- id
- OG001
- title
- GLM-I-Rsp-Golimumab 50 mg Maintenance
- description
- Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
- id
- OG002
- title
- GLM-I-Rsp-Golimumab 100 mg Maintenance
- param Type
- NUMBER
- population Description
- Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
- reporting Status
- POSTED
- time Frame
- Week 30 and Week 54
- title
- Number of Participants With Clinical Remission at Both Week 30 and Week 54
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice