Trial · NCT00930553
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
NCT00930553, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2017-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. Trials, record NCT00930553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00930553
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
- NCT number
- NCT00930553
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,314 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- alemtuzumab
- First posted
- 2009-06-30
- Last updated
- 2017-05-15
- Other registries' IDs
- eudract:2009-010788-18
- Results first posted
- 2017-05-15
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively) | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation. |
| Primary | Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | Baseline (Year 0 of initial studies) up to Year 4 | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. |
| Primary | Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment | Year 1 prior to retreatment, Year 1, 2, 3 after retreatment | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment. |
| Primary | Number of Participants With Sustained Accumulation of Disability (SAD) | Baseline (Year 0) up to Year 6 | SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively. |
| Primary | Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison | Baseline (Year 0 of initial studies) up to Year 4 | SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. |
| Secondary | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 | Baseline (Year 0) up to Year 6 | SRD was defined as a ≥1 point decrease in EDSS score lasting \>= 6 months. SRD is only applicable to participants with a baseline EDSS score of \>= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure. |
| Secondary | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study | Extension study (CAMMS03409) baseline up to Extension Year 2 | SRD was defined as a \>=1 point decrease in EDSS score lasting \>=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. |
| Secondary | Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6 | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 \[NCT00530348\] or CAMMS324 \[NCT00548405\]) value from EDSS scores at specified time points. |
| Secondary | Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison | Baseline (Year 0 of initial studies) up to Year 4 | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively. |
| Secondary | Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment | Retreatment baseline, Year 1, 2 and 3 after retreatment baseline | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate (ARR) | Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively) | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | relapses per participant per year | NUMBER |
| PRIMARY | Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | Baseline (Year 0 of initial studies) up to Year 4 | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | relapses per participant per year | NUMBER |
| PRIMARY | Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment | Year 1 prior to retreatment, Year 1, 2, 3 after retreatment | Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study. | relapses per participant per year | NUMBER |
| PRIMARY | Number of Participants With Sustained Accumulation of Disability (SAD) | Baseline (Year 0) up to Year 6 | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison | Baseline (Year 0 of initial studies) up to Year 4 | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 | Baseline (Year 0) up to Year 6 | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study | Extension study (CAMMS03409) baseline up to Extension Year 2 | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6 | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for Alemtuzumab Treatment CAMMS323 Extension group and Alemtuzumab Treatment CAMMS324 Extension group, respectively), Year 3, 4, 5, 6 | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison | Baseline (Year 0 of initial studies) up to Year 4 | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | units on a scale | MEAN |
| SECONDARY | Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment | Retreatment baseline, Year 1, 2 and 3 after retreatment baseline | Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study. | units on a scale | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS323 Extension | Year 3 | 0.19 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS324 Extension | Year 3 | 0.22 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS323 Extension | Year 4 | 0.16 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS324 Extension | Year 4 | 0.24 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS323 Extension | Year 5 | 0.15 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS324 Extension | Year 5 | 0.19 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS323 Extension | Year 6 | 0.12 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) | Alemtuzumab Treatment CAMMS324 Extension | Year 6 | 0.16 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab) | 0.42 | 95% Confidence Interval 0.28 to 0.64 | relapses per participant per year | |
| Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) | 0.14 | 95% Confidence Interval 0.09 to 0.21 | relapses per participant per year |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alemtuzumab | 1,314 | |
| Overall Study | Participants Entered From CAMMS223 | Alemtuzumab | 141 | |
| Overall Study | Participants Entered From CAMMS323 | Alemtuzumab | 488 | |
| Overall Study | Participants Entered From CAMMS324 | Alemtuzumab | 685 | |
| Overall Study | COMPLETED | Alemtuzumab | 1,091 | |
| Overall Study | NOT COMPLETED | Alemtuzumab | 223 |
Source ClinicalTrials.gov
Adverse events399
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 | Tachycardia | Cardiac disorders | Alemtuzumab | 86 | 1,314 | |
| other | Autoimmune thyroiditis | Endocrine disorders | Alemtuzumab | 67 | 1,314 | |
| other | Basedow's disease | Endocrine disorders | Alemtuzumab | 165 | 1,314 | |
| other | Hyperthyroidism | Endocrine disorders | Alemtuzumab | 142 | 1,314 | |
| other | Hypothyroidism | Endocrine disorders | Alemtuzumab | 140 | 1,314 | |
| other | Vision blurred | Eye disorders | Alemtuzumab | 75 | 1,314 | |
| other | Abdominal pain | Gastrointestinal disorders | Alemtuzumab | 72 | 1,314 | |
| other | Constipation | Gastrointestinal disorders | Alemtuzumab | 104 | 1,314 | |
| other | Diarrhoea | Gastrointestinal disorders | Alemtuzumab | 170 | 1,314 | |
| other | Dyspepsia | Gastrointestinal disorders | Alemtuzumab | 71 | 1,314 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alemtuzumab | ||
| Total, other adverse events | Alemtuzumab | 1,225 | 1,314 |
| Total, serious adverse events | Alemtuzumab | 376 | 1,314 |
Source ClinicalTrials.gov
Papers18
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) vs IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab): Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study | Trial comparisons |
| Alemtuzumab Treatment CAMMS323 Extension vs Alemtuzumab Treatment CAMMS324 Extension: Number of Participants With Sustained Accumulation of Disability (SAD) | Trial comparisons |
| Alemtuzumab Treatment CAMMS323 Extension vs Alemtuzumab Treatment CAMMS324 Extension: Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 | Trial comparisons |
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/NCT00930553
GET https://conductscience.org/api/trials/v1/NCT00930553/registered?page=2