Trial · NCT00213135
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
NCT00213135, Phase 3, Completed, EMD Serono; results first posted 2013-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS). Trials, record NCT00213135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00213135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
- NCT number
- NCT00213135
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,326 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Cladribine 5.25 mg/kg, Cladribine 3.5 mg/kg, Placebo
- First posted
- 2005-09-21
- Last updated
- 2014-02-07
- Results first posted
- 2013-12-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Qualifying Relapse Rate | Week 96 | 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. |
| Secondary | Percentage of Relapse-free Participants | Week 96 | 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. |
| Secondary | Time to Disability Progression | Baseline up to Week 96 | 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. |
| Secondary | 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 | Week 96 | Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Qualifying Relapse Rate | Week 96 | The intention-to-treat (ITT) population included all participants who were randomized in the study. | relapses per year | NUMBER |
| SECONDARY | Percentage of Relapse-free Participants | Week 96 | The ITT population included all participants who were randomized in the study. | percentage of participants | NUMBER |
| SECONDARY | Time to Disability Progression | Baseline up to Week 96 | The ITT population included all participants who were randomized in the study. | months | NUMBER |
| SECONDARY | 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 | Week 96 | The ITT population included all participants who were randomized in the study. | lesions | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Qualifying Relapse Rate | Cladribine 5.25 mg/kg | 0.15 | 95% Confidence Interval 0.58 | relapses per year | |
| Annualized Qualifying Relapse Rate | Cladribine 3.5 mg/kg | 0.14 | 95% Confidence Interval 0.59 | relapses per year | |
| Annualized Qualifying Relapse Rate | Placebo | 0.33 | 95% Confidence Interval 0.88 | relapses per year | |
| Percentage of Relapse-free Participants | Cladribine 5.25 mg/kg | 78.9 | percentage of participants | ||
| Percentage of Relapse-free Participants | Cladribine 3.5 mg/kg | 79.7 | percentage of participants | ||
| Percentage of Relapse-free Participants | Placebo | 60.9 | percentage of participants | ||
| Time to Disability Progression | Cladribine 5.25 mg/kg | 13.6 | months | ||
| Time to Disability Progression | Cladribine 3.5 mg/kg | 13.6 | months | ||
| Time to Disability Progression | Placebo | 10.8 | months | ||
| 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 | Cladribine 5.25 mg/kg | CU lesions | 0.38 | Standard Error 0.08 | lesions |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cladribine 5.25 mg/kg | 456 | |
| Overall Study | STARTED | Cladribine 3.5 mg/kg | 433 | |
| Overall Study | STARTED | Placebo | 437 | |
| Overall Study | COMPLETED | Cladribine 5.25 mg/kg | 406 | |
| Overall Study | COMPLETED | Cladribine 3.5 mg/kg | 398 | |
| Overall Study | COMPLETED | Placebo | 380 | |
| Overall Study | NOT COMPLETED | Cladribine 5.25 mg/kg | 50 | |
| Overall Study | NOT COMPLETED | Cladribine 3.5 mg/kg | 35 | |
| Overall Study | NOT COMPLETED | Placebo | 57 |
Source ClinicalTrials.gov
Adverse events483
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cladribine 5.25 mg/kg | 23 | 454 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cladribine 3.5 mg/kg | 27 | 430 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 21 | 435 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Cladribine 5.25 mg/kg | 39 | 454 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Cladribine 3.5 mg/kg | 34 | 430 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 28 | 435 | |
| other | Depression | Psychiatric disorders | Cladribine 5.25 mg/kg | 25 | 454 | |
| other | Depression | Psychiatric disorders | Cladribine 3.5 mg/kg | 18 | 430 | |
| other | Depression | Psychiatric disorders | Placebo | 13 | 435 | |
| other | Diarrhoea | Gastrointestinal disorders | Cladribine 5.25 mg/kg | 31 | 454 |
1 to 10 of 483Source ClinicalTrials.gov
See all 483 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cladribine 5.25 mg/kg | ||
| Total, all-cause mortality | Cladribine 3.5 mg/kg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Cladribine 5.25 mg/kg | 324 | 454 |
| Total, other adverse events | Cladribine 3.5 mg/kg | 286 | 430 |
| Total, other adverse events | Placebo | 242 | 435 |
| Total, serious adverse events | Cladribine 5.25 mg/kg | 41 | 454 |
| Total, serious adverse events | Cladribine 3.5 mg/kg | 36 | 430 |
| Total, serious adverse events | Placebo | 28 | 435 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00213135
GET https://conductscience.org/api/trials/v1/NCT00213135/events?page=2