Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

This study has been terminated.
(The biological effect seen with natalizumab was not sufficient to warrant further development in RA.)
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00083759
First received: June 1, 2004
Last updated: June 1, 2009
Last verified: April 2009
Results First Received: January 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: natalizumab
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient entered 24 May 2004, study terminated 28 February 2005. A total of 299 patients were evaluable for safety and 273 patients for efficacy. Study conducted in Argentina, Australia, Canada, Czech Republic, Poland, Slovakia, and the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who met these criteria were randomized to natalizumab or placebo: aged 18-75 with a diagnosis of rheumatoid arthritis (RA) Functional Class 1-3 for ≥ 6 months, on a stable dose of methotrexate (MTX), having ≥ 10 painful/tender joints, and with elevated C-reactive protein. Stratification based on baseline number of painful/tender joints.

Reporting Groups
  Description
Natalizumab Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
Placebo Placebo IV infusions + methotrexate (MTX)

Participant Flow:   Overall Study
    Natalizumab     Placebo  
STARTED     150 [1]   149 [2]
COMPLETED     66     66  
NOT COMPLETED     84     83  
Adverse Event                 5                 3  
Lost to Follow-up                 1                 0  
Death                 1                 1  
Inadequate Therapeutic Response                 32                 35  
Subject Withdrew Consent                 2                 2  
Non-Compliance                 1                 0  
Sponsor's Discretion                 28                 29  
Other                 14                 13  
[1] 150 subjects enrolled, 137 (Modified Intention-to-Treat [MITT] Population) for efficacy analyses
[2] 149 subjects enrolled, 136 (Modified Intention-to-Treat [MITT] Population) for efficacy analyses



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Natalizumab Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
Placebo Placebo IV infusions + methotrexate (MTX)
Total Total of all reporting groups

Baseline Measures
    Natalizumab     Placebo     Total  
Number of Participants  
[units: participants]
  137     136     273  
Age  
[units: years]
Mean ± Standard Deviation
  50.9  ± 10.5     53.6  ± 10.4     52.3  ± 10.5  
Gender  
[units: participants]
     
Female     111     107     218  
Male     26     29     55  
Baseline Count of Painful/Tender Joints  
[units: participants]
     
<20     44     43     87  
>20     93     93     186  



  Outcome Measures
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1.  Primary:   American College of Rheumatology (ACR)20.   [ Time Frame: Month 6 ]

2.  Secondary:   American College of Rheumatology (ACR)50   [ Time Frame: Month 6 ]

3.  Secondary:   American College of Rheumatology (ACR)70   [ Time Frame: Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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
The study was terminated prematurely on 28 February 2005. The biological effect seen with natalizumab was not sufficient to warrant further development in RA.  


Results Point of Contact:  
Name/Title: Senior Director, Clinical Development
Organization: Elan Pharmaceuticals, Inc
phone: 1-650-877-0900


No publications provided


ClinicalTrials.gov Identifier: NCT00083759     History of Changes
Other Study ID Numbers: ELN100226-RA201
Study First Received: June 1, 2004
Results First Received: January 27, 2009
Last Updated: June 1, 2009
Health Authority: United States: Food and Drug Administration