Adults 18 to 65, any sex, with Multiple Sclerosis (MS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or HigherPrimary· 3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day. Score of 8.0 is defined as Essent
Group
Value
95% CI
Cohort A
8.2
6.2 – 10.6
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or HigherSecondary· At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as "intermittent or unilateral constant assistance (cane, crutch and brace) required to walk about 100 meters with or without resting".
Group
Value
95% CI
Cohort A
13.9
11.4 – 16.8
Clinical and Demographic Characteristic: Age, Disease DurationSecondary· At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Clinical and demographic characteristics including age and disease duration is reported in the form of long term responders and non-responder. Here long term responder is defined as study participants not requiring disease modifying drug (DMD) 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responders: Age at study visit 1
Group
Value
95% CI
Cohort A
50.5
± 10.65
Non-responders: Age at study visit 1
Group
Value
95% CI
Cohort A
47.1
± 9.47
Long term responder: Disease duration
Group
Value
95% CI
Cohort A
19.82
± 9.161
Non-responder: Disease duration
Group
Value
95% CI
Cohort A
16.82
± 8.321
Number of Participants in Each Category of Clinical and Demographic CharacteristicsSecondary· At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Clinical and demographic characteristics included gender, race, disease classification (relapsing remitting multiple sclerosis \[RRMS\], Secondary Progressive Multiple Sclerosis \[SPMS\], unknown \& no MS disease), Prior use of DMDs \& high-disease activity (HAD) status, education level and employment status. Number of participants in each category of clinical and demographic characteristics were reported in form of long term responders \& non-responder. Here long term responder is defined as participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-
Long term responder: Sex (Female)
Group
Value
95% CI
Cohort A
251
Non-responder: Sex (Female)
Group
Value
95% CI
Cohort A
171
Long-term responder: Sex (Male)
Group
Value
95% CI
Cohort A
127
Non-responder: Sex (Male)
Group
Value
95% CI
Cohort A
78
Long term responder: Race (White)
Group
Value
95% CI
Cohort A
368
Non-responder: Race (White)
Group
Value
95% CI
Cohort A
244
Long term responder: Race (Black or African American)
Group
Value
95% CI
Cohort A
1
Non-responder: Race (Black or African American)
Group
Value
95% CI
Cohort A
0
Clinical Characteristic: Expanded Disability Status Scale (EDSS) ScoreSecondary· At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDSS scores range from 0.0 (normal) to 10.0 (dead). Clinical characteristics of EDSS score in form of long-term responders \& non-responder was reported for at parent study baseline (based on retrospective data collection \[based on chart review\] at study visit 1) \& study visit 1. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in pare
Long-term responders: EDSS score at parent study baseline
Group
Value
95% CI
Cohort A
2.44
± 1.292
Non-responders: EDSS score at parent study baseline
Group
Value
95% CI
Cohort A
2.38
± 1.251
Long term responder: EDSS score at study visit 1
Group
Value
95% CI
Cohort A
3.23
± 2.121
Non-responder: EDSS score at study visit 1
Group
Value
95% CI
Cohort A
3.32
± 2.102
Clinical Characteristic: Number of RelapsesSecondary· At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Relapse was defined as participant-reported symptoms \& objectively observed signs typical of an acute inflammatory demyelinating event in CNS, developing acutely or sub-acutely with duration of at least 24 hours, in absence of fever or infection. Clinical characteristics of number of relapses during last year before enrollment of parent study (it is reported based on retrospective data collection \[based on chart review\] at study visit 1) in the form of long-term responders \& non-responder was reported. Here long term responder is defined as study participants not requiring DMD 4 years or l
Long-term responders: number of relapses during last year before enrollment of parent study
Group
Value
95% CI
Cohort A
1.3
± 0.64
Non-responders: number of relapses during last year before enrollment of parent study
Group
Value
95% CI
Cohort A
1.3
± 0.56
Number of Total T1-weighted (T1-W) LesionsSecondary· At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Total number of T1-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responder
Group
Value
95% CI
Cohort A
12.7
± 8.97
Non-responder
Group
Value
95% CI
Cohort A
16.1
± 10.90
Number of Total T2-weighted (T2-W) LesionsSecondary· At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Total number of T2-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responder
Group
Value
95% CI
Cohort A
20.2
± 18.67
Non-responder
Group
Value
95% CI
Cohort A
25.1
± 18.17
T1-weighted (T1-W) Lesion VolumeSecondary· At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
T1-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responder
Group
Value
95% CI
Cohort A
1.655
± 1.3953
Non-responder
Group
Value
95% CI
Cohort A
6.773
± 6.4788
T2-weighted (T2-W) Lesion VolumeSecondary· At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
T2-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responder
Group
Value
95% CI
Cohort A
4.920
± 6.7665
Non-responder
Group
Value
95% CI
Cohort A
14.664
± 13.8109
Total Brain VolumeSecondary· At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Brain volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Long-term responder
Group
Value
95% CI
Cohort A
1472.559
± 59.9500
Non-responder
Group
Value
95% CI
Cohort A
1417.431
± 109.8668
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to study visit 2 (Up to approximately 6 months and Retrospective AEs data collection based on chart review of participants from end of parent studies; NCT00213135, NCT00641537 and NCT00725985).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A
Serious: 1/662 (0%)
Deaths: 0/662
Serious adverse events (1 terms)
Reaction
System
Cohort A
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06868459 — Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Mul
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NCT05395936 — Mastectomy Flap Temperature Study
· NA
· terminated
NCT05616130 — Pathological Myeloid Activation After Sepsis and Trauma
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NCT04541212 — Identification and Evaluation of Patients at Risk of Developing Cardiotoxicity After Receiving Chemotherapy for Breast C
· active not recruiting
NCT04850105 — A Non-interventional Cohort Safety Study of Patients With hATTR-PN
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Other EMD Serono Research & Development Institute, Inc. trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc.
Last refreshed: 31 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03961204.