How does it work?

Cladribine is a drug which is commonly used to treat certain types of leukemia. It is effective against a type of immune cells, called T cells, which makes it a promising candidate in autoimmune conditions such as MS. It also has a well established safety record in its treatment of other conditions.  

How is it administered?

Cladribine is an oral treatment but standard dosing has yet to be established and this is being investigated in current trials. 

To what type of MS is it targeted?

Relapsing remitting MS 

Most recent trial details

The majority of published data on Cladribine’s safety and effectiveness come from its use in conditions other than MS, however three industry sponsored clinical trials of Cladribine have been carried out involving 262 people with relapsing or progressive forms of MS. These studies have indicated that Cladribine may be able to reduce the number and volume of MS lesions, reduce relapse rate and slow disability progression.  

Current situation

The safety and effectiveness of oral Cladribine is now being assessed both on its own, and in conjunction with beta interferon in two, two year clinical trials for people with relapsing forms of MS.

One late stage, phase III study called CLARITY (CLAdRIbine Tablets in treating MS orally) will assess oral cladribine against a placebo in more than 1300 people with relapsing remitting MS. The results are expected in 2009. An extension of this study will also be conducted to evaluate the longer term safety and effectiveness of oral cladribine. (ClinicalTrials.gov Identifier: NCT00213135)

The ONWARD trial (Oral cladribine added oN to Rebif New Formulation in subjects With Active multiple scleRosis stuDy) will focus on safety, and also evaluate the tolerability and effectiveness of oral Cladribine in conjunction with beta interferon (ClinicalTrials.gov Identifier: NCT00436826)

It has been announced by the drug maker Serono (Geneva) that oral cladribine, has been designated by the U.S. Food and Drug Administration (FDA) as a 'Fast Track Product.' This designation should speed up its future review by the FDA if the drug proves to be safe and effective in treating MS.

 

Side effects

Cladribine can cause a decrease in the number of blood cells in your bone marrow. In the short term Cladribine has been shown to be safe and well tolerated, however long-term data is still required. The safety of the oral tablet formulation is yet to be established.