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A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (CLARITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00213135
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : December 2, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing-Remitting
Interventions Drug: Cladribine 5.25 mg/kg
Drug: Cladribine 3.5 mg/kg
Other: Placebo
Enrollment 1326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Period Title: Overall Study
Started 456 433 437
Completed 406 398 380
Not Completed 50 35 57
Reason Not Completed
Adverse Event             9             5             5
Lost to Follow-up             11             8             4
Protocol Violation             4             4             10
Death             1             1             2
Disease progression             4             5             21
Other             21             12             15
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo Total
Hide Arm/Group Description Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 456 433 437 1326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 456 participants 433 participants 437 participants 1326 participants
39.1  (9.9) 37.9  (10.3) 38.7  (9.9) 38.6  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 456 participants 433 participants 437 participants 1326 participants
Female
312
  68.4%
298
  68.8%
288
  65.9%
898
  67.7%
Male
144
  31.6%
135
  31.2%
149
  34.1%
428
  32.3%
1.Primary Outcome
Title Annualized Qualifying Relapse Rate
Hide Description A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The intention-to-treat (ITT) population included all participants who were randomized in the study.
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description:
Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Overall Number of Participants Analyzed 456 433 437
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses per year
0.15
(0.12 to 0.17)
0.14
(0.12 to 0.17)
0.33
(0.29 to 0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cladribine 5.25 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wald Chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.35 to 0.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cladribine 3.5 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wald Chi-square test
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.34 to 0.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Relapse-free Participants
Hide Description A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized in the study.
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description:
Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Overall Number of Participants Analyzed 456 433 437
Measure Type: Number
Unit of Measure: percentage of participants
78.9 79.7 60.9
3.Secondary Outcome
Title Time to Disability Progression
Hide Description Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.
Time Frame Baseline up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized in the study.
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description:
Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Overall Number of Participants Analyzed 456 433 437
Measure Type: Number
Unit of Measure: months
13.6 13.6 10.8
4.Secondary Outcome
Title Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan
Hide Description Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were randomized in the study.
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description:
Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
Overall Number of Participants Analyzed 456 433 437
Least Squares Mean (Standard Error)
Unit of Measure: lesions
CU lesions 0.38  (0.08) 0.43  (0.08) 1.72  (0.08)
Active T1 Gd+ lesions 0.11  (0.05) 0.12  (0.05) 0.91  (0.05)
Active T2 lesions 0.33  (0.06) 0.38  (0.07) 1.43  (0.06)
Time Frame Baseline up to Week 96
Adverse Event Reporting Description Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
 
Arm/Group Title Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Hide Arm/Group Description Cladribine tablet 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 tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
All-Cause Mortality
Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/454 (9.03%)   36/430 (8.37%)   28/435 (6.44%) 
Blood and lymphatic system disorders       
Lymphopenia * 1  1/454 (0.22%)  3/430 (0.70%)  0/435 (0.00%) 
Neutropenia * 1  1/454 (0.22%)  1/430 (0.23%)  0/435 (0.00%) 
Leukopenia * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Pancytopenia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Thrombocytopenia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Cardiac disorders       
Acute myocardial infarction * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Angina pectoris * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Arrhythmia * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Bundle branch block left * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Cardiac hypertrophy * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Cardio-respiratory arrest * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Cardiomyopathy * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Myocardial infarction * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Prinzmetal angina * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Endocrine disorders       
Hyperthyroidism * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Eye disorders       
Eyelid ptosis * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Colitis ulcerative * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Food poisoning * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Gastric ulcer * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Gastritis erosive * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Gastrointestinal motility disorder * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Haemorrhoids * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Ileus * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Inguinal hernia * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Nausea * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Pancreatitis acute * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Pancreatitis relapsing * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Peritonitis * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Small intestinal perforation * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Toothache * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Vomiting * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
General disorders       
Chest pain * 1  1/454 (0.22%)  0/430 (0.00%)  1/435 (0.23%) 
Pyrexia * 1  1/454 (0.22%)  0/430 (0.00%)  1/435 (0.23%) 
Asthenia * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Drowning * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Non-cardiac chest pain * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Oedema peripheral * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  2/454 (0.44%)  1/430 (0.23%)  0/435 (0.00%) 
Hepatitis toxic * 1  0/454 (0.00%)  1/430 (0.23%)  1/435 (0.23%) 
Cholecystitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Cholecystitis acute * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Hepatic cyst * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Hepatitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hepatitis acute * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hepatosplenomegaly * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Liver disorder * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Immune system disorders       
Hypersensitivity * 1  2/454 (0.44%)  0/430 (0.00%)  0/435 (0.00%) 
Infections and infestations       
Pneumonia * 1  3/454 (0.66%)  3/430 (0.70%)  3/435 (0.69%) 
Adnexitis * 1  2/454 (0.44%)  0/430 (0.00%)  0/435 (0.00%) 
Appendicitis * 1  0/454 (0.00%)  0/430 (0.00%)  2/435 (0.46%) 
Pyelonephritis * 1  0/454 (0.00%)  2/430 (0.47%)  0/435 (0.00%) 
Urinary tract infection * 1  1/454 (0.22%)  1/430 (0.23%)  0/435 (0.00%) 
Actinomycosis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Chronic sinusitis * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Cystitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Endometritis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hepatitis C * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Herpes zoster * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Herpes zoster infection neurological * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Herpes zoster oticus * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Influenza * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Lung abscess * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Myocarditis bacterial * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Orchitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Respiratory tract infection * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Salpingo-oophoritis * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Subcutaneous abscess * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Tuberculosis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/454 (0.00%)  2/430 (0.47%)  0/435 (0.00%) 
Fall * 1  0/454 (0.00%)  2/430 (0.47%)  0/435 (0.00%) 
Concussion * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Facial bones fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Femoral neck fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Femur fracture * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Joint dislocation * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Lumbar vertebral fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Overdose * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Pneumothorax traumatic * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Postoperative ileus * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Radius fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Rib fracture * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Subdural haematoma * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Tibia fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Upper limb fracture * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Wound dehiscence * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Metabolism and nutrition disorders       
Cachexia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hyperglycaemia * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Hypoproteinaemia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  1/454 (0.22%)  0/430 (0.00%)  1/435 (0.23%) 
Arthritis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Bone pain * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Intervertebral disc protrusion * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Myalgia * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Osteitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Uterine leiomyoma * 1  2/454 (0.44%)  3/430 (0.70%)  0/435 (0.00%) 
Cervix carcinoma stage 0 * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Malignant melanoma * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Myelodysplastic syndrome * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Ovarian cancer * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Pancreatic carcinoma metastatic * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Nervous system disorders       
Altered state of consciousness * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Convulsion * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Epilepsy * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Facial spasm * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Haemorrhagic stroke * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Syncope * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1  1/454 (0.22%)  1/430 (0.23%)  1/435 (0.23%) 
Pregnancy * 1  1/454 (0.22%)  1/430 (0.23%)  1/435 (0.23%) 
Ectopic pregnancy * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Psychiatric disorders       
Suicide attempt * 1  2/454 (0.44%)  0/430 (0.00%)  0/435 (0.00%) 
Completed suicide * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Delirium * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Depression * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Intentional self-injury * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Mental disorder * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Panic attack * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Schizophrenia, paranoid type * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Renal and urinary disorders       
Calculus ureteric * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Nephrolithiasis * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Nephrosclerosis * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Renal artery stenosis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Renal colic * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Renal failure chronic * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Reproductive system and breast disorders       
Breast dysplasia * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Menorrhagia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Metrorrhagia * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Ovarian cyst * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Uterine haemorrhage * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  2/454 (0.44%)  0/430 (0.00%)  1/435 (0.23%) 
Pulmonary embolism * 1  1/454 (0.22%)  0/430 (0.00%)  1/435 (0.23%) 
Asthma * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Lung infiltration * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Pulmonary oedema * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Skin and subcutaneous tissue disorders       
Hidradenitis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Lichen sclerosus * 1  0/454 (0.00%)  1/430 (0.23%)  0/435 (0.00%) 
Purpura * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Rash generalised * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Skin reaction * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Vascular disorders       
Arterial disorder * 1  0/454 (0.00%)  0/430 (0.00%)  1/435 (0.23%) 
Deep vein thrombosis * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
Hypertension * 1  1/454 (0.22%)  0/430 (0.00%)  0/435 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cladribine 5.25 mg/kg Cladribine 3.5 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   324/454 (71.37%)   286/430 (66.51%)   242/435 (55.63%) 
Blood and lymphatic system disorders       
Leukopenia * 1  39/454 (8.59%)  23/430 (5.35%)  3/435 (0.69%) 
Lymphopenia * 1  142/454 (31.28%)  92/430 (21.40%)  8/435 (1.84%) 
Ear and labyrinth disorders       
Vertigo * 1  23/454 (5.07%)  14/430 (3.26%)  11/435 (2.53%) 
Gastrointestinal disorders       
Diarrhoea * 1  31/454 (6.83%)  30/430 (6.98%)  29/435 (6.67%) 
Nausea * 1  49/454 (10.79%)  43/430 (10.00%)  39/435 (8.97%) 
General disorders       
Fatigue * 1  27/454 (5.95%)  20/430 (4.65%)  26/435 (5.98%) 
Influenza like illness * 1  27/454 (5.95%)  34/430 (7.91%)  31/435 (7.13%) 
Infections and infestations       
Influenza * 1  34/454 (7.49%)  27/430 (6.28%)  27/435 (6.21%) 
Nasopharyngitis * 1  58/454 (12.78%)  62/430 (14.42%)  56/435 (12.87%) 
Upper respiratory tract infection * 1  52/454 (11.45%)  54/430 (12.56%)  42/435 (9.66%) 
Urinary tract infection * 1  32/454 (7.05%)  23/430 (5.35%)  39/435 (8.97%) 
Investigations       
Lymphocyte count decreased * 1  26/454 (5.73%)  13/430 (3.02%)  0/435 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  23/454 (5.07%)  27/430 (6.28%)  21/435 (4.83%) 
Back pain * 1  39/454 (8.59%)  34/430 (7.91%)  28/435 (6.44%) 
Pain in extremity * 1  24/454 (5.29%)  16/430 (3.72%)  20/435 (4.60%) 
Nervous system disorders       
Headache * 1  94/454 (20.70%)  104/430 (24.19%)  75/435 (17.24%) 
Psychiatric disorders       
Depression * 1  25/454 (5.51%)  18/430 (4.19%)  13/435 (2.99%) 
Insomnia * 1  14/454 (3.08%)  25/430 (5.81%)  17/435 (3.91%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain * 1  24/454 (5.29%)  19/430 (4.42%)  25/435 (5.75%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00213135    
Other Study ID Numbers: 25643
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: September 30, 2013
Results First Posted: December 2, 2013
Last Update Posted: February 7, 2014