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Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)

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ClinicalTrials.gov Identifier: NCT00367237
Recruitment Status : Completed
First Posted : August 22, 2006
Results First Posted : July 7, 2009
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: None (Open Label);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: Infliximab + methotrexate (IFX + MTX)
Drug: Methotrexate (MTX)
Enrollment 115
Recruitment Details 115 subjects (57 infliximab (IFX) + MTX and 58 MTX), but only 110 subjects (56 and 54) were considered intent to treat (ITT). Furthermore, 99 subjects (51 + 48) were in a treatment group at Week 16 for Primary Endpoint evaluation.
Pre-assignment Details  
Arm/Group Title Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX)
Hide Arm/Group Description Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week Oral methotrexate (MTX) 15 mg/week
Period Title: Overall Study
Started 57 [1] 58 [1]
Completed 47 47
Not Completed 10 11
Reason Not Completed
Adverse Event             7             2
Lost to Follow-up             1             0
Withdrawal by Subject             0             4
Protocol Violation             2             5
[1]
Number of subjects randomized
Arm/Group Title Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX) Total
Hide Arm/Group Description Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week Oral methotrexate (MTX) 15 mg/week Total of all reporting groups
Overall Number of Baseline Participants 56 54 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 56 participants 54 participants 110 participants
40.1
(20 to 65)
42.3
(21 to 65)
41.2
(20 to 65)
[1]
Measure Description: ITT population
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 110 participants
Female
29
  51.8%
21
  38.9%
50
  45.5%
Male
27
  48.2%
33
  61.1%
60
  54.5%
1.Primary Outcome
Title Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16
Hide Description >=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.
Time Frame between baseline and week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects from Intent-to-Treat population in each arm at Week 16
Arm/Group Title Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX)
Hide Arm/Group Description:
Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Oral methotrexate (MTX) 15 mg/week
Overall Number of Participants Analyzed 51 48
Measure Type: Number
Unit of Measure: participants
44 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab + Methotrexate (IFX + MTX), Methotrexate (MTX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0210
Comments Comparison of treatments (IFX + MTX versus MTX)
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages of respondents
Estimated Value 19.61
Confidence Interval 95%
3.27 to 35.95
Estimation Comments Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Infliximab + Methotrexate (IFX + MTX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion of Responders
Estimated Value 0.863
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Methotrexate (MTX)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion of Responders
Estimated Value 0.667
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable
Hide Description This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Time Frame between baseline and week 16
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)
Hide Description This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Time Frame between baseline and week 16
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Adverse Events
Hide Description This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Time Frame between baseline and week 16
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description

Safety analyses included all subjects who received at least 1 dose of study medication

Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"

 
Arm/Group Title Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX)
Hide Arm/Group Description Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week Oral methotrexate (MTX) 15 mg/week
All-Cause Mortality
Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Infliximab + Methotrexate (IFX + MTX) Methotrexate (MTX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/57 (3.51%)      0/54 (0.00%)    
General disorders     
Infusion related reaction  1  1/57 (1.75%)  1 0/54 (0.00%)  0
Infections and infestations     
Pulmonary Tuberculosis  1  1/57 (1.75%)  1 0/54 (0.00%)  0
Indicates events were collected by 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 + Methotrexate (IFX + MTX) Methotrexate (MTX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/57 (21.05%)      10/54 (18.52%)    
Gastrointestinal disorders     
Abdominal Pain Upper  1  0/57 (0.00%)  0 3/54 (5.56%)  3
Investigations     
Alanine Aminotransferase Increased  1  6/57 (10.53%)  6 5/54 (9.26%)  5
Blood Bilirubin Increased  1  2/57 (3.51%)  2 3/54 (5.56%)  3
Transaminases Increased  1  3/57 (5.26%)  4 1/54 (1.85%)  1
Nervous system disorders     
Headache  1  3/57 (5.26%)  3 1/54 (1.85%)  2
Indicates events were collected by 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.
Investigator must provide 30 days written notice to sponsor prior to submission for publication/presentation, so that sponsor can review the material(s). If the parties disagree concerning the appropriateness of the material for publication, the investigator must meet with sponsor prior to publication/presentation, in order to make good faith efforts to discuss and resolve any disagreements.
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: NCT00367237    
Other Study ID Numbers: P04422
EUDRACT #: 2005-002189-12
First Submitted: August 18, 2006
First Posted: August 22, 2006
Results First Submitted: March 19, 2009
Results First Posted: July 7, 2009
Last Update Posted: April 11, 2017