Trial Outcomes & Findings for Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) (NCT NCT00394589)
NCT ID: NCT00394589
Last Updated: 2017-04-11
Results Overview
Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
43 participants
Primary outcome timeframe
Between Screening (Week <=1) and Week 24
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
|
Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
|
Control
Continuation of infliximab 3 mg/kg every 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
18
|
|
Overall Study
COMPLETED
|
6
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
7
|
Reasons for withdrawal
| Measure |
Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
|
Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
|
Control
Continuation of infliximab 3 mg/kg every 8 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
3
|
|
Overall Study
Protocol Violation
|
4
|
0
|
2
|
Baseline Characteristics
Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)
Baseline characteristics by cohort
| Measure |
Increased Dose
n=14 Participants
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
|
Increased Frequency
n=11 Participants
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
|
Control
n=18 Participants
Continuation of infliximab 3 mg/kg every 8 weeks
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Between Screening (Week <=1) and Week 24Population: Intent-to-treat population; subjects with available data at both Baseline and Week 24
Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).
Outcome measures
| Measure |
Increased Dose
n=5 Participants
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
|
Increased Frequency
n=7 Participants
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
|
Control
n=5 Participants
Continuation of infliximab 3 mg/kg every 8 weeks
|
|---|---|---|---|
|
Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.
|
-0.4 Score on a Scale
Standard Deviation 1.27
|
-1.6 Score on a Scale
Standard Deviation 1.23
|
-1.0 Score on a Scale
Standard Deviation 1.90
|
Adverse Events
Infliximab*3mg/kg+1*Vial Q8W
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Infliximab*3mg/kg Q6W
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control*Infliximab*3mg/kg Q8W
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab*3mg/kg+1*Vial Q8W
n=14 participants at risk
|
Infliximab*3mg/kg Q6W
n=11 participants at risk
|
Control*Infliximab*3mg/kg Q8W
n=18 participants at risk
|
|---|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
General disorders
ASTHENIA
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
General disorders
INFUSION RELATED REACTION
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
General disorders
PYREXIA
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Nervous system disorders
BRAIN STEM SYNDROME
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Nervous system disorders
DIZZINESS
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
SOMNOLENCE
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Infliximab*3mg/kg+1*Vial Q8W
n=14 participants at risk
|
Infliximab*3mg/kg Q6W
n=11 participants at risk
|
Control*Infliximab*3mg/kg Q8W
n=18 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
14.3%
2/14 • Number of events 2
|
0.00%
0/11
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
General disorders
OEDEMA PERIPHERAL
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
PURULENT DISCHARGE
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Infections and infestations
SINUSITIS
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Infections and infestations
TINEA MANUUM
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Investigations
HEPATIC ENZYME INCREASED
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/14
|
0.00%
0/11
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
SUFFOCATION FEELING
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/14
|
9.1%
1/11 • Number of events 3
|
0.00%
0/18
|
|
Vascular disorders
ANGIODYSPLASIA
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/18
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place