At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,326 enrolled

Drug / intervention

Cladribine 5.25 mg/kg +2 moredrug

Likely dose

Cladribine 5.25 mg/kg total (0.875 mg/kg cumulative dose over 4-5 consecutive days at Weeks 1, 5, 9, 13, 48, and 52)AI-extracted

Key inclusion· 7

✓Age 18-65 years at informed consent
✓Definite MS by McDonald criteria
✓Relapsing-remitting disease with 1 or more relapses within 12 months prior to Study Day 1
✓Clinically stable with no relapse within 28 days prior to Study Day 1

Key exclusion· 11

✕Secondary progressive MS (SPMS) or primary progressive MS (PPMS)
✕Prior DMD use within 3 months, or 2 or more prior DMD treatment failures based on efficacy
✕Prior use of cladribine, mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate, or natalizumab
✕Significant leukopenia (WBC <0.5× lower limit of normal) within 28 days prior to Study Day 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00213135

NCT00213135Phase 3Completed

Compare CT.gov

A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

EMD Serono·interventional·Posted Sep 21, 2005·Updated Feb 7, 2014

In Brief

A Phase 3 clinical trial evaluating Cladribine 5.25 mg/kg, Cladribine 3.5 mg/kg, and 1 other intervention for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 1,326 participants.

Detailed Summary

The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMultiple Sclerosis, Relapsing-Remitting

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2005

First PostedSep 2005

Primary CompletionNov 2008

TodayJul 2026

First PostedSep 21, 2005

Enrollment StartApr 1, 2005

Primary CompletionNov 1, 2008

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Cladribine 5.25 mg/kgdrug

Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.

Cladribine 3.5 mg/kgdrug

Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.

Placeboother

Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.