ClinicalTrials.gov
ClinicalTrials.gov Menu

Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3) (Re³)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00394589
Recruitment Status : Terminated (Study enrollment was stopped due to insufficient subject accrual.)
First Posted : November 1, 2006
Results First Posted : January 21, 2010
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Infliximab Increased Frequency
Drug: Infliximab Increased Dose
Drug: Infliximab Control
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Increased Dose Increased Frequency Control
Hide Arm/Group Description 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks Continuation of infliximab 3 mg/kg every 8 weeks
Period Title: Overall Study
Started 14 11 18
Completed 6 8 11
Not Completed 8 3 7
Reason Not Completed
Adverse Event             2             1             2
Lack of Efficacy             2             2             3
Protocol Violation             4             0             2
Arm/Group Title Increased Dose Increased Frequency Control Total
Hide Arm/Group Description 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks Continuation of infliximab 3 mg/kg every 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 14 11 18 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 11 participants 18 participants 43 participants
58.7  (13.0) 58.6  (16.1) 57.7  (12.3) 58.3  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 11 participants 18 participants 43 participants
Female
11
  78.6%
9
  81.8%
14
  77.8%
34
  79.1%
Male
3
  21.4%
2
  18.2%
4
  22.2%
9
  20.9%
1.Primary Outcome
Title Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score.
Hide Description 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).
Time Frame Between Screening (Week <=1) and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population; subjects with available data at both Baseline and Week 24
Arm/Group Title Increased Dose Increased Frequency Control
Hide Arm/Group Description:
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Continuation of infliximab 3 mg/kg every 8 weeks
Overall Number of Participants Analyzed 5 7 5
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-0.4  (1.27) -1.6  (1.23) -1.0  (1.90)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab*3mg/kg+1*Vial Q8W Infliximab*3mg/kg Q6W Control*Infliximab*3mg/kg Q8W
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Infliximab*3mg/kg+1*Vial Q8W Infliximab*3mg/kg Q6W Control*Infliximab*3mg/kg Q8W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab*3mg/kg+1*Vial Q8W Infliximab*3mg/kg Q6W Control*Infliximab*3mg/kg Q8W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/11 (0.00%)      2/18 (11.11%)    
Ear and labyrinth disorders       
VERTIGO  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
General disorders       
ASTHENIA  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
INFUSION RELATED REACTION  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
PYREXIA  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Immune system disorders       
ANAPHYLACTIC REACTION  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders       
BRAIN STEM SYNDROME  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
DIZZINESS  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
LOSS OF CONSCIOUSNESS  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
SOMNOLENCE  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders       
DEEP VEIN THROMBOSIS  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab*3mg/kg+1*Vial Q8W Infliximab*3mg/kg Q6W Control*Infliximab*3mg/kg Q8W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/14 (50.00%)      5/11 (45.45%)      5/18 (27.78%)    
Blood and lymphatic system disorders       
ANAEMIA  1  2/14 (14.29%)  2 0/11 (0.00%)  0 0/18 (0.00%)  0
LEUKOPENIA  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Cardiac disorders       
CARDIOVASCULAR DISORDER  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Ear and labyrinth disorders       
TINNITUS  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders       
APHTHOUS STOMATITIS  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
General disorders       
OEDEMA PERIPHERAL  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations       
LARYNGITIS  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
NASOPHARYNGITIS  1  1/14 (7.14%)  1 0/11 (0.00%)  0 1/18 (5.56%)  1
PURULENT DISCHARGE  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
SINUSITIS  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
TINEA MANUUM  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
TOOTH INFECTION  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
UPPER RESPIRATORY TRACT INFECTION  1  1/14 (7.14%)  1 1/11 (9.09%)  1 0/18 (0.00%)  0
Investigations       
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
HEPATIC ENZYME INCREASED  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/14 (7.14%)  1 0/11 (0.00%)  0 1/18 (5.56%)  1
BURSITIS  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
PAIN IN JAW  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
HEADACHE  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
SYNCOPE  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
Reproductive system and breast disorders       
VAGINAL HAEMORRHAGE  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders       
OROPHARYNGEAL PAIN  1  0/14 (0.00%)  0 0/11 (0.00%)  0 1/18 (5.56%)  1
SUFFOCATION FEELING  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders       
DERMATITIS  1  0/14 (0.00%)  0 1/11 (9.09%)  1 0/18 (0.00%)  0
PRURITUS  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
RASH  1  0/14 (0.00%)  0 1/11 (9.09%)  1 1/18 (5.56%)  1
URTICARIA  1  0/14 (0.00%)  0 1/11 (9.09%)  3 0/18 (0.00%)  0
Vascular disorders       
ANGIODYSPLASIA  1  1/14 (7.14%)  1 0/11 (0.00%)  0 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00394589     History of Changes
Other Study ID Numbers: P04249
First Submitted: October 31, 2006
First Posted: November 1, 2006
Results First Submitted: October 28, 2009
Results First Posted: January 21, 2010
Last Update Posted: April 11, 2017