Colitis, Ulcerative
Conditions
Keywords
Colitis, Ulcerative, Golimumab, CNTO 148
Brief summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Detailed description
This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.
Interventions
BIOLOGICALPlacebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
BIOLOGICALGolimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
BIOLOGICALGolimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
BIOLOGICALGolimumab 200 mg
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
Sponsors
Merck Sharp & Dohme LLC
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) * Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
Exclusion criteria
* Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) * Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) * Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) * Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C * Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Clinical Response Through Week 54 | Induction Baseline, Week 0 through Week 54 | Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Remission at Both Week 30 and Week 54 | Week 30 and Week 54 | 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. |
| Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | Week 30 and Week 54 | Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | Week 30 and Week 54 | 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. |
| Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | Week 54 | 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. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, India, Israel, Japan, Latvia, Lithuania, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Sweden, Ukraine, United States
Participant flow
Pre-assignment details
Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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 injection matching to golimumab administered every 4 weeks through Week 52 in the 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. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment. | 156 |
| 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. | 154 |
| 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). 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. | 154 |
| Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 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 adjustment. | 129 |
| PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | 230 |
| GLM-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. | 405 |
| Total | 1,228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind Period (Week 0-54) | Adverse Event | 17 | 12 | 12 | 12 | 30 | 50 | 0 | 0 | 0 | 0 |
| Double Blind Period (Week 0-54) | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Double Blind Period (Week 0-54) | Lost to Follow-up | 1 | 2 | 1 | 0 | 3 | 7 | 0 | 0 | 0 | 0 |
| Double Blind Period (Week 0-54) | Other | 6 | 12 | 10 | 11 | 14 | 34 | 0 | 0 | 0 | 0 |
| Double Blind Period (Week 0-54) | Unsatisfactory therapeutic effect | 19 | 17 | 22 | 18 | 56 | 124 | 0 | 0 | 0 | 0 |
| Open Label Study Extension (Week 54-228) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 10 | 8 | 54 | 0 |
| Open Label Study Extension (Week 54-228) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Open Label Study Extension (Week 54-228) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 6 | 0 |
| Open Label Study Extension (Week 54-228) | Unsatisfactory therapeutic effect | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 | 34 | 3 |
| Open Label Study Extension (Week 54-228) | Unspecified reasons | 0 | 0 | 0 | 0 | 0 | 0 | 63 | 14 | 87 | 0 |
Baseline characteristics
| Characteristic | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | GLM-I-Rsp-Golimumab 50 mg Maintenance | GLM-I-Rsp-Golimumab 100 mg Maintenance | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | PBO-I-nonRsp-Golimumab 100 mg Maintenance | GLM-I-nonRsp-Golimumab 100 mg Maintenance | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 14.05 | 41.4 years STANDARD_DEVIATION 13.84 | 39.1 years STANDARD_DEVIATION 13.11 | 38 years STANDARD_DEVIATION 13.27 | 40.3 years STANDARD_DEVIATION 12.67 | 41.2 years STANDARD_DEVIATION 13.6 | 40.3 years STANDARD_DEVIATION 13.44 |
| Sex: Female, Male Female | 81 Participants | 77 Participants | 65 Participants | 68 Participants | 99 Participants | 138 Participants | 528 Participants |
| Sex: Female, Male Male | 75 Participants | 77 Participants | 89 Participants | 61 Participants | 131 Participants | 267 Participants | 700 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 88 / 156 | 102 / 154 | 94 / 154 | 44 / 76 | 15 / 25 | 10 / 14 | 67 / 129 | 140 / 230 | 247 / 405 | 30 / 56 | 43 / 96 | 58 / 93 | 329 / 469 | 6 / 7 | 1 / 1 | 19 / 28 | 11 / 19 | 7 / 10 |
| serious Total, serious adverse events | 12 / 156 | 13 / 154 | 22 / 154 | 8 / 76 | 6 / 25 | 1 / 14 | 7 / 129 | 34 / 230 | 63 / 405 | 7 / 56 | 8 / 96 | 11 / 93 | 91 / 469 | 1 / 7 | 0 / 1 | 7 / 28 | 1 / 19 | 0 / 10 |
Outcome results
Primary
Number of Participants in Clinical Response Through Week 54
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Time frame: Induction Baseline, Week 0 through Week 54
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | Number of Participants in Clinical Response Through Week 54 | 48 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | Number of Participants in Clinical Response Through Week 54 | 71 Participants |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | Number of Participants in Clinical Response Through Week 54 | 75 Participants |
Comparison: Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: 0.01Cochran-Mantel-Haenszel
Comparison: Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
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.
Time frame: Week 30 and Week 54
Population: Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | 13 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | 19 Participants |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | 21 Participants |
Comparison: Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.p-value: 0.365Cochran-Mantel-Haenszel
Comparison: Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.p-value: 0.098Cochran-Mantel-Haenszel
Secondary
Number of Participants With Clinical Remission at Both Week 30 and Week 54
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.
Time frame: Week 30 and Week 54
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | Number of Participants With Clinical Remission at Both Week 30 and Week 54 | 24 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | Number of Participants With Clinical Remission at Both Week 30 and Week 54 | 35 Participants |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | Number of Participants With Clinical Remission at Both Week 30 and Week 54 | 42 Participants |
Comparison: 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.p-value: 0.122Cochran-Mantel-Haenszel
Comparison: 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.p-value: 0.004Cochran-Mantel-Haenszel
Secondary
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
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.
Time frame: Week 54
Population: Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | 16 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | 22 Participants |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | 19 Participants |
Comparison: Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: 0.279Cochran-Mantel-Haenszel
Comparison: Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: 0.423Cochran-Mantel-Haenszel
Secondary
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
Time frame: Week 30 and Week 54
Population: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | 41 Participants |
| GLM-I-Rsp-Golimumab 50 mg Maintenance | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | 63 Participants |
| GLM-I-Rsp-Golimumab 100 mg Maintenance | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | 64 Participants |
Comparison: Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: 0.011Cochran-Mantel-Haenszel
Comparison: Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.p-value: 0.002Cochran-Mantel-Haenszel