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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:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00083759
First received: June 1, 2004
Last updated: July 14, 2016
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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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.


  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.


Results Point of Contact:  
Name/Title: Biogen Study Medical Director
Organization: Biogen
e-mail: clinicaltrials@biogen.com



Responsible Party: Biogen
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: July 14, 2016
Health Authority: United States: Food and Drug Administration