Placebo Controlled Study in Subjects With Relapsing Forms of MS to Eva
Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323.
What it found
The trial was stopped early because the treatment was not working.
Reason given: The study was discontinued due to unfavorable interim analysis
This trial finished 17 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Ucb-1184197
Integrin alpha-4 inhibitor
Placebo
- placebo
What it measured
Main measures
The cumulative number of newly active lesions on standardized brain MRI scans after 24 weeks of treatment (Week 28).
Cumulative number of newly active lesions from baseline to Week 28.
MRI lesionsPrimary Efficacy Variable
Other measures (1)
Occurrence of any treatment emergent adverse event.
During up to 24 weeks of treatment.
Safety
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* relapsing form of MS * screening EDSS score 0 - 5.5, inclusive * at least one clinical relapse in the 12 months before screening * active disease, defined by set of MRI activity criteria * failed prior treatment with beta-interferons or glatiramer acetate
Exclusion criteria
* signs of silent infections, including positive tests for HIV1, HIV2 or Hepatitis B or Hepatitis C or tuberculosis * known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation * pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The objective of the study is to evaluate the effect, safety and tolerability of CDP323 in patients with relapsing forms of multiple sclerosis
Papers
Loading reviews and guidelines…
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History
Started
May 2007
Main results due
Nov 2009
Finished
Jul 2010