Sample 63

NCT: NCT04602390 Model: local-qwen-0_5b RAG: rag
Deleted (in GT only) Added (in prediction only) Unchanged

Ground Truth

Inclusion Criteria:Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screeningNeurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (dimethyl fumarate or diroximel fumarate)Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study InvestigatorPatient has signed and understands the ICFExclusion Criteria:Diagnosis of primary progressive MS or secondary progressive MSUncontrolled or significant medical conditions (including active infection or chronic hepatitis) which, in the opinion of the Investigator, preclude participationPatients treated with glatiramer acetate, parenteral steroids or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dosePatients treated with sphingosine-1-phospate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dosePatients treated with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dosePatients treated with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dosePatients previously treated with alemtuzumab, total lymphoid irradiation, mesenchymal stem cell or hematopoietic stem cell transplantation, or tolerance-inducing therapies for MSContraindication to or inability to undergo gadolinium-enhanced magnetic resonance imaging (MRI) scanUse of any investigational drug or experimental procedure within previous 6 months that would interfere with the assessment of ANK-700Patients who are pregnant or breastfeedingPatients receiving any vaccination within 28 days prior to first dosePatient does not agree to limit alcohol intake to 2 drink equivalents or less per day during the study

Prediction

### Revised Eligibility Criteria for Version 8 Clinical Trial
#### Original Eligibility Criteria (Version 7):
**Inclusion Criteria:**
- Diagnosed with RRMS per revised McDonald criteria (2017)
- With an EDSS score ≤ 6.5 at screening
- Neurologically stable with no evidence of relapse within the 28 days before signing the informed consent form (ICF)
**Exclusion Criteria:**
- Diagnosis of primary progressive MS or secondary progressive MS
- Uncontrolled or significant medical conditions (including active infection or chronic hepatitis)
- Which, in the opinion of the Investigator, preclude participation
- Treatment with glatiramer acetate, parenteral steroids, or adrenocorticotropic hormone, β-interferon, plasma exchange within the 3 months prior to first dose
- Treatment with sphingosine-1-phosphate receptor modulators such as fingolimod, ozanimod, or siponimod within 6 months prior to first dose
- Treatment with cytotoxic agents (including, but not limited to, cladribine, mitoxantrone, cyclophosphamide, azathioprine, and methotrexate), laquinimod, teriflunomide, or IV gamma globulin within 12 months prior to first dose
- Treatment with monoclonal antibody therapy (including natalizumab, daclizumab, rituximab, ofatumumab, and ocrelizumab) within 24 months prior to first dose
- Previous treatment with alemtuzumab, total lymphoid irradiation, mesenchymal stem cells or hematopoietic stem cells transplantation, or tolerance-inducing therapies for MS
#### Updated Eligibility Criteria (Version 8):
**Inclusion Criteria:**
- Male or female adults aged 18 to 60 years inclusive at screening
- Diagnosed with RRMS per revised McDonald criteria (2017) with an EDSS score ≤ 6.5 at screening
- Neurologically stable with no evidence of relapse within the 28 days prior to signing the informed consent form (ICF)
- Either not currently receiving disease modifying MS therapy, or currently using fumarate drugs (i.e., dimethyl fumarate, diroximel fumarate)
- Patients must use a highly effective method of birth control or are sterile or postmenopausal as confirmed by study investigator for the first 3 months (through D90) of the study
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
- Patient has signed and understood the ICF
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