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RESTART C0168Z05 Rheumatoid Arthritis Study

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ClinicalTrials.gov Identifier: NCT00714493
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : February 9, 2011
Last Update Posted : September 12, 2013
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Infliximab
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab
Hide Arm/Group Description Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
Period Title: Overall Study
Started 203
Completed 154
Not Completed 49
Reason Not Completed
Adverse Event             11
Death             3
Lack of Efficacy             10
Lost to Follow-up             3
Protocol Violation             12
SUBJECT CHOICE (SUBJECT WITHDREW CONSENT             8
OTHER             2
Arm/Group Title Infliximab
Hide Arm/Group Description Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
Overall Number of Baseline Participants 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants
<=18 years
0
   0.0%
Between 18 and 65 years
171
  84.2%
>=65 years
32
  15.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants
54  (12.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants
Female
161
  79.3%
Male
42
  20.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants
Europe 43
North America 160
1.Primary Outcome
Title Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10
Hide Description Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: Percentage
49.7
2.Secondary Outcome
Title Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase
Hide Description Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: percentage
22.3
3.Secondary Outcome
Title Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26
Hide Description Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: percentage
51.8
4.Secondary Outcome
Title Change From Baseline in Physical Function (HAQ)
Hide Description Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: scale -3 to 3
-0.173  (0.4548)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab 3 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Physical Function (HAQ)
Hide Description Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 151
Mean (Standard Deviation)
Unit of Measure: scale -3 to 3
-0.223  (0.4968)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab 3 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
6.Secondary Outcome
Title Percent of Patients Who Achieved ACR20 at Week 10
Hide Description Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: percentage
28.4
7.Secondary Outcome
Title Percent of Patients Who Achieved ACR20 at Weeks 26.
Hide Description Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infliximab 3 mg/kg
Hide Arm/Group Description:
Infliximab 3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Overall Number of Participants Analyzed 197
Measure Type: Number
Unit of Measure: percentage
35.5
Time Frame All untoward events occurring between the time of obtaining informed consent through Week 30 or early termination were collected, regardless of causality.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab
Hide Arm/Group Description Infliximab 3 mg/kg (intravenously) at weeks 0,2,6; Increase to 5 mg/kg (i.v.) or 7 mg/kg (i.v.) based on EULAR response
All-Cause Mortality
Infliximab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Infliximab
Affected / at Risk (%)
Total   10/203 (4.93%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/203 (0.49%) 
Cardiac disorders   
Cardiac Failure Congestive * 1  2/203 (0.99%) 
Acute Myocardial Infarction * 1  1/203 (0.49%) 
Atrial Fibrillation * 1  1/203 (0.49%) 
Atrioventricular Block Complete * 1  1/203 (0.49%) 
Cardiac Failure * 1  1/203 (0.49%) 
Cardiogenic Shock * 1  1/203 (0.49%) 
Congestive Cardiomyopathy * 1  1/203 (0.49%) 
Myocardial Infarction * 1  1/203 (0.49%) 
General disorders   
Multi-Organ Failure * 1  1/203 (0.49%) 
Immune system disorders   
Hypersensitivity * 1  1/203 (0.49%) 
Infections and infestations   
Erysipelas * 1  1/203 (0.49%) 
Metabolism and nutrition disorders   
Diabetes Mellitus * 1  1/203 (0.49%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid Arthritis * 1  1/203 (0.49%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic Neoplasm * 1  1/203 (0.49%) 
Psychiatric disorders   
Completed Suicide * 1  1/203 (0.49%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism * 1  1/203 (0.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab
Affected / at Risk (%)
Total   54/203 (26.60%) 
Gastrointestinal disorders   
Nausea * 1  11/203 (5.42%) 
Infections and infestations   
Sinusitis * 1  17/203 (8.37%) 
Upper Respiratory Tract Infection * 1  14/203 (6.90%) 
Nervous system disorders   
Headache * 1  11/203 (5.42%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  12/203 (5.91%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Director, Clinical Research - Medical Affairs
Organization: Centocor Ortho Biotech, Inc.
Phone: 215-325-6811
EMail: Ddeckto2@its.jnj.com
Layout table for additonal information
Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00714493    
Obsolete Identifiers: NCT01281449
Other Study ID Numbers: CR013879
C0168Z05 ( Other Identifier: Centocor Ortho Biotech Services, L.L.C. )
First Submitted: July 10, 2008
First Posted: July 14, 2008
Results First Submitted: January 14, 2011
Results First Posted: February 9, 2011
Last Update Posted: September 12, 2013