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An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

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ClinicalTrials.gov Identifier: NCT00760669
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : August 12, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Spondylitis, Ankylosing
Arthritis, Rheumatoid
Psoriasis
Arthritis, Psoriatic
Interventions: Drug: Infliximab; observational study
Drug: Methotrexate; observational study

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants Receiving Infliximab Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.

Participant Flow:   Overall Study
    Participants Receiving Infliximab
STARTED   1061 
COMPLETED   1031 
NOT COMPLETED   30 
Not assessed for overall improvement                18 
Participants missing efficacy assessment                6 
Participants with overlapping cases                1 
Took drug before entering in contract                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were performed on safety analysis set. Data presented only for 1055 participants as they were part of safety analysis set. Safety analysis set included all participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Participants Receiving Infliximab Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.

Baseline Measures
   Participants Receiving Infliximab 
Overall Participants Analyzed 
[Units: Participants]
 1055 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.32  (13.84) 
Gender 
[Units: Participants]
 
Female   363 
Male   692 


  Outcome Measures

1.  Primary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30   [ Time Frame: Baseline and Week 30 ]

2.  Primary:   Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30   [ Time Frame: Baseline and Week 30 ]

3.  Primary:   Change From Baseline in C-Reactive Protein (CRP) at Week 30   [ Time Frame: Baseline and Week 30 ]

4.  Primary:   Change From Baseline in Number of Swollen Joints at Week 30   [ Time Frame: Baseline and Week 30 ]

5.  Primary:   Change From Baseline in Number of Tender Joints at Week 30   [ Time Frame: Baseline and Week 30 ]

6.  Primary:   Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30   [ Time Frame: Baseline and Week 30 ]

7.  Primary:   Overall Efficacy Assessment   [ Time Frame: Baseline up to Week 30 ]

8.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 30 ]

9.  Primary:   Number of Participants With Unexpected Adverse Events   [ Time Frame: Baseline up to Week 30 ]

10.  Primary:   Number of Participants With Adverse Drug Reactions   [ Time Frame: Baseline up to Week 30 ]

11.  Primary:   Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction   [ Time Frame: Baseline up to Week 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
phone: +82-2-2094-4879



Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00760669     History of Changes
Other Study ID Numbers: CR100768
REMICADEAKS4004 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Submitted: September 24, 2008
First Posted: September 26, 2008
Results First Submitted: June 6, 2013
Results First Posted: August 12, 2013
Last Update Posted: October 29, 2013