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Trial record 1 of 1 for:    NCT00732875
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A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00732875
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : July 21, 2009
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Intervention Biological: Infliximab + methotrexate (MTX)
Enrollment 92
Recruitment Details Subjects showing clinical response at Week 30 of a previous double-blind study of infliximab vs placebo (P04280,NCT00202852) were eligible for this study. A total of 105 subjects were eligible (67 from previous placebo & 38 from previous infliximab group) for this extension study, among whom a total of 92 enrolled to participate in the extension.
Pre-assignment Details Of the 92 enrolled subjects, 61 were from the placebo group and 31 from the infliximab group of the previous study.
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Period Title: Overall Study
Started 92
Completed 57 [1]
Not Completed 35
Reason Not Completed
Adverse Event             16
Withdrawal by Subject             6
Lack of Efficacy             13
[1]
These participants continued treatment until trial was completed by Sponsor.
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
50.1  (11.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
<30 years 2
Between 30 and less than 40 years 14
Between 40 and less than 50 years 29
Between 50 and less than 60 years 29
Between 60 and less than 70 years 15
>=70 years 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
86
  93.5%
Male
6
   6.5%
1.Primary Outcome
Title Number of Subjects Experiencing Any Adverse Event
Hide Description [Not Specified]
Time Frame throughout entire study (61 +/- 28.9 weeks on average)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included regardless of how long they stayed in the study.
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description:
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
76
2.Primary Outcome
Title Number of Subjects Experiencing Serious Adverse Event
Hide Description Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.
Time Frame throughout entire study (61 +/- 28.9 weeks on average)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included regardless of how long they stayed in the study.
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description:
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
12
3.Primary Outcome
Title Number of Subjects Experiencing Any Infection
Hide Description [Not Specified]
Time Frame throughout entire study (61 +/- 28.9 weeks on average)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included regardless of how long they stayed in the study
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description:
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: participants
41
Time Frame [Not Specified]
Adverse Event Reporting Description During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
 
Arm/Group Title Open Label Infliximab + Methotrexate
Hide Arm/Group Description Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
All-Cause Mortality
Open Label Infliximab + Methotrexate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Infliximab + Methotrexate
Affected / at Risk (%) # Events
Total   12/92 (13.04%)    
Blood and lymphatic system disorders   
Anaemia  1  1/92 (1.09%)  1
Gastrointestinal disorders   
gastric ulcer  1  1/92 (1.09%)  2
General disorders   
chest discomfort  1  1/92 (1.09%)  1
inflammation  1  1/92 (1.09%)  1
infusion related reaction  1  1/92 (1.09%)  1
ulcer  1  1/92 (1.09%)  1
Hepatobiliary disorders   
cholecystitis acute  1  1/92 (1.09%)  1
Immune system disorders   
anaphylactoid reaction  1  1/92 (1.09%)  1
Infections and infestations   
chronic sinusitis  1  2/92 (2.17%)  2
pneumonia cryptococcal  1  1/92 (1.09%)  1
pyelonephritis acute  1  1/92 (1.09%)  1
Injury, poisoning and procedural complications   
thoracic vertebral fracture  1  1/92 (1.09%)  1
Musculoskeletal and connective tissue disorders   
arthralgia  1  2/92 (2.17%)  2
Psychiatric disorders   
confusional state  1  1/92 (1.09%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnoea  1  1/92 (1.09%)  1
oropharyngeal discomfort  1  1/92 (1.09%)  1
rhinitis hypertrophic  1  1/92 (1.09%)  1
Skin and subcutaneous tissue disorders   
pruritus  1  1/92 (1.09%)  1
urticaria  1  2/92 (2.17%)  2
Vascular disorders   
flushing  1  1/92 (1.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Infliximab + Methotrexate
Affected / at Risk (%) # Events
Total   50/92 (54.35%)    
Gastrointestinal disorders   
diarrhoea  1  5/92 (5.43%)  6
nausea  1  8/92 (8.70%)  11
vomiting  1  5/92 (5.43%)  5
General disorders   
chills  1  6/92 (6.52%)  8
Infections and infestations   
nasopharyngitis  1  6/92 (6.52%)  6
upper respiratory tract infection  1  19/92 (20.65%)  27
Investigations   
alanine aminotransferase increased  1  6/92 (6.52%)  7
aspartate aminotransferase increased  1  5/92 (5.43%)  6
Nervous system disorders   
headache  1  8/92 (8.70%)  9
Respiratory, thoracic and mediastinal disorders   
cough  1  6/92 (6.52%)  7
dyspnoea  1  5/92 (5.43%)  7
Skin and subcutaneous tissue disorders   
pruritus  1  11/92 (11.96%)  13
urticaria  1  9/92 (9.78%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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.
All proposed publications/presentations by the investigators or their personnel/associates resulting from/relating to this study must be submitted to SP Korea for review and approval before submission for publication/presentation. If the proposed publication/presentation contains patentable subject matter, which, at SP Korea’s sole discretion, warrants intellectual property protection, SP Korea may delay any publication or presentation for the purpose of pursuing such protection.
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: NCT00732875     History of Changes
Other Study ID Numbers: P05645
First Submitted: August 8, 2008
First Posted: August 12, 2008
Results First Submitted: June 2, 2009
Results First Posted: July 21, 2009
Last Update Posted: April 13, 2017