CLARITY Extension Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.

Key facts

Study ID

NCT00641537

Run by

EMD Serono Research & Development Institute, Inc.

People needed

867

Starts

2008-02-29

Expected to finish

2011-12-31

Last updated by the study team

2020-12-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Randomized in Trial 25643 and satisfied one of the following:
• Completed randomized treatment course and scheduled visits for the full 96 weeks; or
• Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
• Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
• Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
• Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
• No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
• All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:
• Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
• Leukocytes (total white blood cell) = 4.1 to 12.3*10\^3 per microliter
• Absolute lymphocyte count (ALC) = 1.02 to 3.36*10\^3 per microliter
• Absolute neutrophil count (ANC) = 2.03 to 8.36*10\^3 per microliter
• Platelet count = 140 to 450*10\^3 per microliter
• Other protocol-defined inclusion/exclusion criteria may apply

You may not qualify if…

• Participants who were not enrolled in Trial 25643
• Participant has moderate to severe renal impairment
• Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
• Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
• Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1

Where it is running

• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Northbrook, Illinois, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Henderson, Nevada, United States
• Research Site — Newark, New Jersey, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Tulsa, Oklahoma, United States
• Research Site — Medford, Oregon, United States
• Research Site — Seattle, Washington, United States
• Research Site — Tacoma, Washington, United States
• Research Site — Charleston, West Virginia, United States
• Research Site — Camperdown, Australia
• Research Site — Melbourne, Australia
• Research Site — Victoria, Australia
• Research Site — Linz, Austria
• Research Site — Diepenbeek, Belgium
• Research Site — Esneux, Belgium
• Research Site — Recife, Brazil
• Research Site — Pleven, Bulgaria
• Research Site — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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