Text Size

Transition to Rebif New Formulation (TRANSFER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00619307
First received: February 8, 2008
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
Results First Received: May 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Relapsing Multiple Sclerosis
Interventions: Drug: Rebif New Formulation + prophylactic Ibuprofen
Drug: Rebif New Formulation + ibuprofen PRN

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from 16 July 2007 and attended the last visit on 11 April 2008. One hundred and twenty three subjects gave informed consent and 117 were enrolled. Of these, all were treated except one subject scheduled to receive prophylactic ibuprofen, who withdrew consent before treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 17 active centres, 6 centres in France and 11 centres in Germany. Screening visit took place within 2 weeks of randomisation. Six subjects were screening failures.

Reporting Groups
  Description
Transition With Prophylactic Ibuprofen

subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.

Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
Transition With PRN Ibuprofen subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.

Participant Flow:   Overall Study
    Transition With Prophylactic Ibuprofen     Transition With PRN Ibuprofen  
STARTED     60     57  
COMPLETED     56     53  
NOT COMPLETED     4     4  
Adverse Event                 0                 1  
Lost to Follow-up                 0                 1  
Protocol Violation                 3                 0  
Withdrew consent                 1                 0  
Severe migraine                 0                 1  
MS attack plus steroids                 0                 1  



  Baseline Characteristics
  Show Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score   [ Time Frame: 4 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score   [ Time Frame: 4 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score   [ Time Frame: 4 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score   [ Time Frame: 4 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score   [ Time Frame: 4 weeks ]
  Show Outcome Measure 5


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Liz Gedney/Clinical Trial Leader
Organization: EMD Serono
phone: (+1 781) 681-2179
e-mail: liz.gedney@emdserono.com


No publications provided


Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00619307     History of Changes
Other Study ID Numbers: 27571
Study First Received: February 8, 2008
Results First Received: May 11, 2010
Last Updated: September 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices