Trial Outcomes & Findings for Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) (NCT NCT02092285)
NCT ID: NCT02092285
Last Updated: 2019-03-15
Results Overview
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
205 participants
Primary outcome timeframe
Baseline (Week 0), Week 6, Week 30, Week 54
Results posted on
2019-03-15
Participant Flow
A total of 225 participants were screened; 205 participants started treatment after meeting eligibility criteria.
Participant milestones
| Measure |
Golimumab
The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Induction Phase
STARTED
|
205
|
|
Induction Phase
COMPLETED
|
170
|
|
Induction Phase
NOT COMPLETED
|
35
|
|
Maintenance Phase & Follow-up
STARTED
|
170
|
|
Maintenance Phase & Follow-up
COMPLETED
|
60
|
|
Maintenance Phase & Follow-up
NOT COMPLETED
|
110
|
Reasons for withdrawal
| Measure |
Golimumab
The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Induction Phase
Adverse Event
|
7
|
|
Induction Phase
Physician Decision
|
4
|
|
Induction Phase
Pregnancy
|
1
|
|
Induction Phase
Relapse/Recurrence
|
7
|
|
Induction Phase
Withdrawal by Subject
|
2
|
|
Induction Phase
Lack of Efficacy
|
14
|
|
Maintenance Phase & Follow-up
Adverse Event
|
22
|
|
Maintenance Phase & Follow-up
Lost to Follow-up
|
1
|
|
Maintenance Phase & Follow-up
Non-compliance with study drug
|
2
|
|
Maintenance Phase & Follow-up
Physician Decision
|
10
|
|
Maintenance Phase & Follow-up
Pregnancy
|
1
|
|
Maintenance Phase & Follow-up
Protocol Violation
|
11
|
|
Maintenance Phase & Follow-up
Relapse/recurrence
|
29
|
|
Maintenance Phase & Follow-up
Withdrawal by Subject
|
11
|
|
Maintenance Phase & Follow-up
Lack of Efficacy
|
23
|
Baseline Characteristics
Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)
Baseline characteristics by cohort
| Measure |
Golimumab
n=205 Participants
The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 15.09 • n=5 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
3 Participants
n=5 Participants
|
|
Age, Customized
Adults (between 18 and 64 years)
|
184 Participants
n=5 Participants
|
|
Age, Customized
From 65 to 84 years
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
|
Partial Mayo Score
|
6.4 Units on a scale
STANDARD_DEVIATION 1.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0), Week 6, Week 30, Week 54Population: The analysis population for the evaluation of efficacy during the maintenance period was the Full Analysis Set (FAS205) consisting of participants who received at least 1 dose of golimumab.
The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.
Outcome measures
| Measure |
Golimumab
n=205 Participants
The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54
|
24.9 Percentage of Participants
Interval 19.1 to 31.4
|
Adverse Events
Golimumab
Serious events: 49 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Golimumab
n=205 participants at risk
The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Cardiac disorders
BRADYCARDIA
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.49%
1/205 • Number of events 2 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Eye disorders
CORNEAL EROSION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Eye disorders
ULCERATIVE KERATITIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
COLITIS
|
2.4%
5/205 • Number of events 6 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
11.2%
23/205 • Number of events 23 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
RECTAL FISSURE
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
ANAL ABSCESS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
APPENDICITIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
CLOSTRIDIUM BACTERAEMIA
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
DIVERTICULITIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
PNEUMONIA
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
SEPSIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
WOUND INFECTION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
1.5%
3/205 • Number of events 3 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.49%
1/205 • Number of events 2 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Nervous system disorders
MIGRAINE
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.98%
2/205 • Number of events 2 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.49%
1/205 • Number of events 1 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
Other adverse events
| Measure |
Golimumab
n=205 participants at risk
The first induction dose of SC golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
|
|---|---|
|
Gastrointestinal disorders
COLITIS
|
7.3%
15/205 • Number of events 15 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
13.7%
28/205 • Number of events 29 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
7.3%
15/205 • Number of events 15 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.8%
20/205 • Number of events 22 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Nervous system disorders
HEADACHE
|
7.3%
15/205 • Number of events 18 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.8%
14/205 • Number of events 15 • Up to 66 weeks
The analysis population for the evaluation of safety was the All Participants as Treated population consisting of any participant who received study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator agrees to provide to the Sponsor 45 days prior to submission, review copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regards to proprietary information, data accuracy, fairness, and compliance with federal regulations.
- Publication restrictions are in place
Restriction type: OTHER