Autopsy report · NCT00381810

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

“During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months after it had already started.
• Ran for about 5 years 8 months before it stopped.
• 31 participants enrolled.
• Results were posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Genentech, Inc.

Sponsor type

Industry

Conditions

Lupus Erythematosus, Systemic

Interventions

Rituximab; Methylprednisolone; Acetaminophen; Diphenhydramine

Participants

31

Sites

11

Countries

United States

Trials that died the same way

• PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency
  “The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety.” (63% match in meaning)
• To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
  “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.” (62% match in meaning)
• A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
  “The study terminated for safety reasons” (62% match in meaning)
• A Dose Escalation Study to Assess the Safety and Tolerability of HMPL-453 in Patients With Advanced Solid Malignancies
  “The study was terminated on 23AUG2018 for safety reasons.” (62% match in meaning)
• Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
  “The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.” (62% 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.