Sample 77

Evaluation Instructions

Important: Models were tasked with extracting evidence from documents. Some outputs may be low quality and should be scored accordingly.

Your task: Compare the model-generated prediction (right panel) against the ground truth criteria (left panel).

Evaluation scale (0-4):

Consider both content accuracy and completeness. Some predictions may be technically "correct" but incomplete or out of order.

Ground Truth

INCLUSION CRITERIA

  1. Participant has clinical diagnosis of SLE at least 24 weeks prior to screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
  2. At Screening, must have at least one of the following:antinuclear antibody(ANA)+ (titer >= 1:80).anti-dsDNA+.anti-Smith+.
  3. SLEDAI-2K >= 6 despite background therapy as reported and independently adjudicated (clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at Screening.
  4. If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
  5. If participant has rash and PI considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
  6. Score must be re-confirmed at the Baseline visit.
  7. Physician's Global Assessment (PhGA) >= 1 during screening period.
  8. Must be on background treatment, stable for 30 days, at Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg), azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (<=20 mg).
  9. No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

EXCLUSION CRITERIA

  1. Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

Prediction

Here is the modified eligibility criteria for version 18:

Version Context: This task is for the transition from ClinicalTrials.gov version 17 to version 18. The evidence may use different labels (e.g. "Amendment 1", "Version 2.0") that do not always match our version numbers 1:1; use the evidence to infer the intended change.

Original Eligibility Criteria (version 17):

 Background and Rationale: The ABBV-599 (elsubrutinib/upadacitinib) combination is an innovative combination therapy that targets non-overlapping signaling pathways implicated in systemic lupus erythematosus (SLE). As described below, Janus kinase 1 (JAK1) inhibition via upadacitinib is expected to disrupt T cell activation and Type I interferon (IFN) signaling, whereas elsubrutinib (ABBV-105) is expected to inhibit B cell activation and immune complex-driven activation of dendritic cells (and neutrophils).

 Study Objectives and Endpoints: 1. Achievement of SRI-4 at Week 24 2. Achievement of BILAG-Based Combined Lupus Assessment (BICLA) response at Week 24 3. Achievement of Lupus Low Disease Activity State (LLDAS) at Week 24 4. Steroid burden, assessed as change from Baseline at Week 24 5. Number of mild, moderate, or severe flares per patient-year (respectively and overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index (SFI), assessed by number and types of flare per subject through Week 24 6. Change in SLEDAI-2K from Baseline 7. Change in BILAG from Baseline 8. Change in PhGA from Baseline 9. Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 2, 12, 24, and 48 10. Change from Baseline in 36-Item Short Form Health Survey (SF-36) at Weeks 2, 12, 24, and 48 11. Change from Baseline in 30-day follow-up phone call from last dose of study drug 12. Achievement of 50% reduction of tender or swollen lupus joints defined as ≥ 50% decrease in either tender or swollen joints 13. Achievement of 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score (of those starting with CLASI ≥10) 14. Change in SLEDAI-2K from Baseline 15. Change in BILAG from Baseline 16. Change in PhGA from Baseline 17. Change from Baseline in 36-Item Short Form Health Survey (SF-36) at Weeks 2, 12, 24, and 48 18. Change from Baseline in 30-day follow-up phone call from last dose of study drug 19. Stereotypes of SLE in participants 20. Changes in SLEDAI-2K and BILAG from baseline 21. Changes in PhGA from baseline 22. Changes in 36-Item Short Form Health Survey (SF-36) from baseline 23. Changes in 30-day follow-up phone call from last dose of study drug 24. Changes in 36-Item Short Form Health Survey (SF-36) from baseline 25. Changes in 30-day follow-up phone call from last dose of study drug 26. 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