Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis

An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

LBCTR

Registry ID

LBCTR2020030215

Enrollment

Registered

2021-06-11

Start date

2019-08-15

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MS, Multiple Sclerosis

Interventions

No Intervention, except: *Optional blood sample: Patients willing to consent to provide an optional blood sample and who are seen at a site with available capabilities to store and ship samples, will

Purpose: Pharmaco-genetics Testing

blood sampling

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received = 1 course of IMP (Cladribine Tablets or placebo). or Patients with their FCDE randomised in ORACLE MS clinical trial who have received= 1 course of IMP (Cladribine Tablets or placebo). 2. Informed Consent

Exclusion criteria

Exclusion criteria: 1. Medical Conditions: Any condition, including any uncontrolled disease state other than MS, that in the Investigator’s opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation. For the MRI sub-study: 1. Female Participants Who are pregnant 2. Patient taking Cladribine Tablets as part of another study at the time of the start of this study

Design outcomes

Primary

Measure	Time frame
Name: To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.;Timepoints: Proportion of study participants using a wheelchair (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) the majority of the time in the 3 months prior to Study Visit 1 for the CLARITY/CLARITY-EXT and ORACLE MS populations,;Measure: • Expanded Disability Status Scale (EDSS) score of 7.0 or higher (if available), or • Alternative clinical description data in medical records.	—

Measure

Time frame

Name: To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.;Timepoints: Proportion of study participants using a wheelchair (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) the majority of the time in the 3 months prior to Study Visit 1 for the CLARITY/CLARITY-EXT and ORACLE MS populations,;Measure: • Expanded Disability Status Scale (EDSS) score of 7.0 or higher (if available), or • Alternative clinical description data in medical records.

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Secondary

Measure	Time frame
Name: To assess the long-term disability status after treatment with IMP as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: Proportion of study participants with 3-month sustained (i.e. ambulatory disability consistent with EDSS on at least 2 clinic visits no less than 3 months apart);Measure: EDSS of 6.0 or higher in the last year prior to enrollment or corresponding clinical description in medical records;Name: To evaluate differences in clinical characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: Clinical characteristics at Study Visit 1 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last doseb of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Measure: -;Name: To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: MRI characteristics at Study Visit 2 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study	—

Measure

Time frame

Name: To assess the long-term disability status after treatment with IMP as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: Proportion of study participants with 3-month sustained (i.e. ambulatory disability consistent with EDSS on at least 2 clinic visits no less than 3 months apart);Measure: EDSS of 6.0 or higher in the last year prior to enrollment or corresponding clinical description in medical records;Name: To evaluate differences in clinical characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: Clinical characteristics at Study Visit 1 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last doseb of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Measure: -;Name: To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoints: MRI characteristics at Study Visit 2 of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last doseb of IMP and who did not receive disease modifying treatment until Year 4 or later following their last doseb of IMP) compared to those of other study

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Countries

Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Finland, France, Georgia, Germany, Greece, Italy, Latvia, Lebanon, Lithuania, Morocco, Norway, Poland, Portugal, Republic of Korea, Republic of Serbia, Romania, Russian Federation, Spain, Sweden, Switzerland, Tunisia, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr. Bassem Yamout

American University of Beirut Medical Center

-+9613221222

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026