Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) (REMARK)

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: NCT00705289
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 10, 2010
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Biological: Infliximab
Enrollment 728
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg
Hide Arm/Group Description Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
Period Title: Overall Study
Started 728
Completed 597
Not Completed 131
Reason Not Completed
Subject or treating physician's choice             131
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg
Hide Arm/Group Description Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
Overall Number of Baseline Participants 728
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 728 participants
54.1  (13.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 728 participants
Female
571
  78.4%
Male
157
  21.6%
Time since diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 728 participants
9.0  (8.99)
[1]
Measure Description: Data available for 703 participants.
1.Primary Outcome
Title Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age
Hide Description Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg
Hide Arm/Group Description:
Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
Overall Number of Participants Analyzed 662
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.2  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Subjects/ Infliximab 3 mg/kg
Comments Relationship between baseline DAS28 and age (prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Test for non-zero correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Product Moment Correlation
Estimated Value 0.1402
Estimation Comments [Not Specified]
2.Primary Outcome
Title Baseline Raw DAS28 by Time Since Diagnosis
Hide Description Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg
Hide Arm/Group Description:
Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
Overall Number of Participants Analyzed 662
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.2  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Subjects/ Infliximab 3 mg/kg
Comments Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7991
Comments [Not Specified]
Method Test for non-zero correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson Product Moment Correlation
Estimated Value -0.01
Estimation Comments [Not Specified]
3.Primary Outcome
Title Baseline Raw DAS28 by Gender
Hide Description Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg Male Female
Hide Arm/Group Description:
Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 662 140 522
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.2  (1.15) 5.23  (1.11) 5.19  (1.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Male, Female
Comments Relationship between baseline DAS28 and gender (prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7152
Comments [Not Specified]
Method ANOVA
Comments The association between Baseline DAS28 and gender is based on a one-way Anova.
4.Primary Outcome
Title Baseline Raw DAS28 by Country of Residence
Hide Description Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Austria Belgium Denmark France Germany Greece Italy Netherlands Norway Poland Portugal Sweden
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 55 73 24 104 67 78 32 17 41 51 20 100
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.38  (0.90) 5.43  (1.22) 4.57  (1.16) 4.97  (1.12) 5.38  (1.23) 5.15  (1.14) 5.03  (1.05) 5.07  (1.23) 5.39  (1.13) 5.83  (0.87) 5.08  (1.48) 4.96  (1.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Austria, Belgium, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Sweden
Comments Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.
5.Primary Outcome
Title Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Hide Description Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.
Arm/Group Title RA Subjects/ Infliximab 3 mg/kg Early RA, Not Treated With Anti-TNF Established RA, Not Treated With Anti-TNF Established RA, Failed/Did Not Tolerate Another Anti-TNF
Hide Arm/Group Description:
Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).
Subjects with early RA not yet treated with an anti-TNF.
Subjects with established RA not yet treated with an anti-TNF.
Subjects with established RA having failed or not tolerated another anti-TNF.
Overall Number of Participants Analyzed 662 76 447 123
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.2  (1.15) 5.3  (1.16) 5.2  (1.14) 5.3  (1.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RA Subjects/ Infliximab 3 mg/kg
Comments Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Baseline DAS28 Raw Score
Estimated Value 5.2
Confidence Interval 95%
5.1 to 5.3
Parameter Dispersion
Type: Standard Deviation
Value: 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early RA, Not Treated With Anti-TNF
Comments Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Baseline DAS28 Raw Score
Estimated Value 5.3
Confidence Interval 95%
5.0 to 5.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Established RA, Not Treated With Anti-TNF
Comments Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Baseline DAS28 Raw Score
Estimated Value 5.2
Confidence Interval 95%
5.1 to 5.3
Parameter Dispersion
Type: Standard Deviation
Value: 1.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Established RA, Failed/Did Not Tolerate Another Anti-TNF
Comments Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Baseline DAS28 Raw Score
Estimated Value 5.3
Confidence Interval 95%
5.1 to 5.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.16
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Infliximab 3 mg/kg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Infliximab 3 mg/kg
Affected / at Risk (%) # Events
Total   40/721 (5.55%)    
Blood and lymphatic system disorders   
ANAEMIA  1  1/721 (0.14%)  1
Gastrointestinal disorders   
NAUSEA  1  1/721 (0.14%)  1
General disorders   
CHILLS  1  1/721 (0.14%)  1
GAIT DISTURBANCE  1  1/721 (0.14%)  1
HYPERTHERMIA  1  1/721 (0.14%)  1
INFUSION RELATED REACTION  1  2/721 (0.28%)  4
PYREXIA  1  1/721 (0.14%)  1
Hepatobiliary disorders   
CHOLECYSTITIS  1  2/721 (0.28%)  2
Immune system disorders   
HYPERSENSITIVITY  1  1/721 (0.14%)  1
Infections and infestations   
BRONCHOPNEUMONIA  1  1/721 (0.14%)  1
CELLULITIS  1  1/721 (0.14%)  1
DISSEMINATED TUBERCULOSIS  1  1/721 (0.14%)  1
ERYSIPELAS  1  1/721 (0.14%)  1
INFECTION  1  1/721 (0.14%)  1
MASTITIS  1  1/721 (0.14%)  1
PNEUMOCYSTIS JIROVECI PNEUMONIA  1  1/721 (0.14%)  1
PNEUMONIA  1  2/721 (0.28%)  2
PNEUMONIA LEGIONELLA  1  1/721 (0.14%)  1
PYELONEPHRITIS  1  1/721 (0.14%)  1
SALMONELLOSIS  1  1/721 (0.14%)  1
URINARY TRACT INFECTION  1  1/721 (0.14%)  1
Injury, poisoning and procedural complications   
DEVICE FAILURE  1  1/721 (0.14%)  1
SYNOVIAL RUPTURE  1  1/721 (0.14%)  1
Investigations   
HEPATIC ENZYME INCREASED  1  1/721 (0.14%)  1
INVESTIGATION  1  1/721 (0.14%)  1
Metabolism and nutrition disorders   
DIABETES MELLITUS INADEQUATE CONTROL  1  1/721 (0.14%)  1
HYPERGLYCAEMIA  1  1/721 (0.14%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/721 (0.14%)  1
ARTHRITIS  1  1/721 (0.14%)  1
RHEUMATOID ARTHRITIS  1  1/721 (0.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BREAST CANCER  1  1/721 (0.14%)  1
OESOPHAGEAL NEOPLASM  1  1/721 (0.14%)  1
Nervous system disorders   
SPEECH DISORDER  1  1/721 (0.14%)  1
Respiratory, thoracic and mediastinal disorders   
ALVEOLITIS  1  1/721 (0.14%)  1
OROPHARYNGEAL PAIN  1  1/721 (0.14%)  1
PULMONARY OEDEMA  1  1/721 (0.14%)  1
Skin and subcutaneous tissue disorders   
ANGIOEDEMA  1  1/721 (0.14%)  1
Social circumstances   
JOINT PROSTHESIS USER  1  1/721 (0.14%)  1
Surgical and medical procedures   
HERNIA REPAIR  1  1/721 (0.14%)  1
Vascular disorders   
HYPERTENSION  1  1/721 (0.14%)  1
PHLEBITIS  1  1/721 (0.14%)  1
THROMBOSIS  1  2/721 (0.28%)  2
VENOUS THROMBOSIS LIMB  1  1/721 (0.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab 3 mg/kg
Affected / at Risk (%) # Events
Total   0/721 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and the sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705289    
Other Study ID Numbers: P04250
First Submitted: June 23, 2008
First Posted: June 26, 2008
Results First Submitted: September 3, 2009
Results First Posted: June 10, 2010
Last Update Posted: July 30, 2015