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The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 365 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 67 words
    • Study description expanded, about 3 words
  2. Eligibility criteria expanded, about 45 words
    • Study description expanded, about 1 word
    v364
  3. Re-verified, no change to tracked fieldsv363
  4. Eligibility criteria expanded, about 16 words
    • Study description shortened, about 1 word
    v362
  5. 3 versions Re-verified since Feb 4, 2026, no change to tracked fieldsv359-v361
Show 43 earlier versionsHide 43 earlier versions
  1. Primary completion date: Aug 1, 2026 to Aug 1, 2027
    • Study completion date: Aug 1, 2026 to Aug 2, 2027
    v358
  2. 2 versions Re-verified since May 15, 2025, no change to tracked fieldsv356-v357
  3. Study description revised
    • Eligibility criteria expanded, about 2 words
    v355
  4. Re-verified, no change to tracked fieldsv354
  5. Eligibility criteria shortened, about 66 wordsv353
  6. 8 versions Re-verified since Dec 4, 2024, no change to tracked fieldsv345-v352
  7. Eligibility criteria shortened, about 1 word
    • Study description shortened, about 2 words
    v344
  8. Study description revised
    • Eligibility criteria shortened, about 2 words
    v343
  9. Eligibility criteria expanded, about 11 wordsv342
  10. Primary and study completion dates: Aug 1, 2025 to Aug 1, 2026v341
  11. Primary and study completion dates: Aug 1, 2024 to Aug 1, 2025v340
  12. 3 versions Re-verified since Mar 9, 2024, no change to tracked fieldsv337-v339
  13. Study Status, Eligibilityv336
  14. Re-verified, no change to tracked fieldsv335
  15. Start date changed from estimate of Dec 14, 2023 to Dec 7, 2023v334
  16. Start date: Dec 13, 2023 to Dec 14, 2023v333
  17. Start date: Dec 10, 2023 to Dec 13, 2023v332
  18. Start date: Dec 7, 2023 to Dec 10, 2023v331
  19. Start date: Dec 5, 2023 to Dec 7, 2023v330
  20. Start date: Dec 4, 2023 to Dec 5, 2023v329
  21. Start date: Dec 3, 2023 to Dec 4, 2023v328
  22. Start date: Nov 30, 2023 to Dec 3, 2023v327
  23. Start date: Nov 28, 2023 to Nov 30, 2023v326
  24. Start date: Nov 27, 2023 to Nov 28, 2023v325
  25. Start date: Nov 26, 2023 to Nov 27, 2023v324
  26. Start date: Nov 23, 2023 to Nov 26, 2023v323
  27. Start date: Nov 22, 2023 to Nov 23, 2023v322
  28. Start date: Nov 21, 2023 to Nov 22, 2023v321
  29. Start date: Nov 20, 2023 to Nov 21, 2023v320
  30. Start date: Nov 19, 2023 to Nov 20, 2023v319
  31. Start date: Nov 16, 2023 to Nov 19, 2023v318
  32. Start date: Nov 15, 2023 to Nov 16, 2023v317
  33. Start date: Nov 12, 2023 to Nov 15, 2023v316
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
Trial Details
NCT Number NCT05440422
Lead Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)		 Systemic Lupus Erythematosus, Cardiovascular Disease, Premature Atherosclerosis
Related terms Cardiovascular Diseases, Lupus Erythematosus, Systemic
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov