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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02255656

Registration number

NCT02255656

Ethics application status

Date submitted

30/09/2014

Date registered

2/10/2014

Titles & IDs

Public title

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

Scientific title

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

Secondary ID [1]

2013-003884-71

Secondary ID [2]

LPS13649

Universal Trial Number (UTN)

Trial acronym

TOPAZ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Relapsing Remitting Multiple Sclerosis

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - alemtuzumab GZ402673

Experimental: Alemtuzumab - All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).

Treatment: Drugs: alemtuzumab GZ402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

Assessment method [1]

An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \[i.e. up to a maximum of 5.6 years\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

Timepoint [1]

From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Primary outcome [2]

Number of Participants With Infusion-Associated Reactions (IAR)

Assessment method [2]

Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.

Timepoint [2]

Within 24 hours of any alemtuzumab infusion

Primary outcome [3]

Number of Participants With Adverse Events of Special Interest (AESI)

Assessment method [3]

Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.

Timepoint [3]

From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Primary outcome [4]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

Assessment method [4]

Criteria for potentially clinically significant laboratory abnormalities included: * Hemoglobin (Hb): less than or equal to (\<=)115 grams per liter (g/L)(Male \[M\]), \<= 95 g/L (Female\[ F\]); greater than or equal to (\>=)185 g/L (M), \>= 165 g/L (F); Decrease From Baseline (DFB) \>= 20 g/L. * Hematocrit: \<= 0.37 volume/volume (v/v) (M); \<= 0.32 v/v (F); \>= 0.55 v/v (M); \>= 0.5 v/v (F). * Red Blood Cells (RBCs): \>=6 \*10\^12/L. * Platelets: \<100 \*10\^9/L; \>=700 \*10\^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Timepoint [4]

From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Secondary outcome [1]

Annualized Relapse Rate

Assessment method [1]

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.

Timepoint [1]

Up to a maximum duration of 5.6 years

Secondary outcome [2]

Proportion of Participants Who Were Relapse Free

Assessment method [2]

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.

Timepoint [2]

Up to a maximum duration of 5.6 years

Secondary outcome [3]

Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Assessment method [3]

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.

Timepoint [3]

Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Secondary outcome [4]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan

Assessment method [4]

Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.

Timepoint [4]

Up to a maximum duration of 5.6 years

Secondary outcome [5]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan

Assessment method [5]

Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.

Timepoint [5]

Up to a maximum duration of 5.6 years

Secondary outcome [6]

Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan

Assessment method [6]

Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.

Timepoint [6]

Up to a maximum duration of 5.6 years

Secondary outcome [7]

Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60

Assessment method [7]

The total lesion volume (T1 lesions) was measured by MRI scan.

Timepoint [7]