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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519700-28-01 | EU Trial (CTIS) Number |
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The HiHat trial is a Phase 2 study aimed at evaluating the safety and feasibility of sequential treatment with rituximab and cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The study follows a prospective, open-label, single-arm design, with 60 RRMS patients receiving both treatments in a controlled regimen: two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. Participants are monitored over 24 months through clinical assessments, MRI, and biomarker analyses. The primary objective is to evaluate whether the rate of serious adverse events (SAE) is acceptably low. Secondary objectives include assessing impacts on MRI lesion count, relapse rates, disability progression, quality of life, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with relapsing-remitting multiple sclerosis (RRMS) | Experimental | The study population will consist of subjects with RRMS with less than 10 years disease duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential treatment with rituximab and cladribine | Drug | Two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Serious Adverse Events | The primary objective of the study is to evaluate whether the SAE rate associated with sequential treatment of rituximab followed by cladribine is acceptably low. The proportion of patients with at least one treatment-related SAE (relationship ≥ possible) will be reported. | From start of treatment until end of follow-up at 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) lesions | Proportion of patients with a new MRI lesion will be reported. | The first scan made after the treatment course has been completed (week 12) will be compared with the scan at 2 years to determine if new lesions have occurred. |
| Relapses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joachim Burman, MD, PhD | Contact | +46 18 611 50 88 | joachim.burman@uu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Falu Lasarett, Neurologen | Falun | 79182 | Sweden |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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The proportion of patients with at least one confirmed clinical relapse will be reported. |
| From start of treatment until the end of follow-up at 2 years. |
| Disability | The proportion of patients with confirmed disability worsening, rated with the Kurtzke Expanded Disability Status Scale (EDSS, ranges from 0 to 10). | EDSS at baseline will be compared with EDSS at end of follow-up at 2 years. |
| Symbol Digit Modalities Test (SDMT) | The proportion of patients with worsened, unchanged, or improved SDMT (score range 0-110, higher numbers are better) will be reported. A change by at least 4 points on the SDMT will be considered a clinically meaningful change. | SDMT at baseline is compared with SDMT at end of follow-up at 2 years. |
| Quality of life (physical) measured by MSIS-29 (Multiple Sclerosis Impact Scale) | The proportion of patients with improvement in MSIS-29 physical (rated 0-100, higher is worse) will be reported. A change by 8 points in the physical domain will be considered a clinically meaningful change. | Baseline compared with end of follow-up at 2 years. |
| Quality of life (MSIS-29 psychological) | The proportion of patients with improvement in MSIS-29 psychological (rated 0-100, higher is worse) will be reported. A change by 6 points in the psychological domain will be considered a clinically meaningful change. | Baseline compared with end of follow-up at 2 years. |
| Treatment-related Adverse Events | The proportion of patients with treatment-related adverse events of mild or moderate severity (relationship ≥ probable) to the study medication. | From start of treatment to end of follow-up at 2 years. |
| Gävle sjukhus, Neurologmottagningen | Gävle | 80324 | Sweden |
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| Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken | Karlstad | 651 85 | Sweden |
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| Uppsala University Hospital | Uppsala | 75185 | Sweden |
|
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |