Autopsy report · NCT01364389

A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica

“Data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 11 months before it stopped.
• 16 participants enrolled.
• Results were posted on the registry 2 years 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Polymyalgia Rheumatica; Inflammatory Diseases

Interventions

AIN457; ACZ885; Prednisone; Placebo

Participants

16

Sites

6

Countries

Germany, Italy, United Kingdom, United States

Trials that died the same way

• A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
  “The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required” (55% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.