A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR

NCT01821040 on ClinicalTrials.gov Phase 3 Mundipharma Research Limited (industry) Started 2013-03-31 Terminated

Riskier than 13% of active trials

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (238 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Terminated on 2014-04-30, after 2013-03-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-04-30. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: cancercellpriorhormonaleffective
Phrases that lowered it: and safetyefficacy andsubjectssafety ofthe efficacy
Sponsor's past termination rate: 36.4% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 50 (lowers risk) · Who can join
Phase: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Blinding: double (raises risk) · Design
Maximum age: not given (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports in the prior 12 months: 13143 (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 13.6% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 58123 (lowers risk) · Drug's FDA history
Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Disease area, dermatology: Yes (raises risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 50 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 11 (typical: 32)
Sponsor's past termination rate: 36.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 58123 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 13143 (typical: 412.5)
Drug's FAERS reports marked serious: 74.7% (typical: 85.6%)
Drug's FAERS reports with a death: 13.6% (typical: 15.9%)

Disease area and drugs

Disease areas: dermatology, musculoskeletal
Drugs matched to FDA substances: prednisone

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Delayed Release Prednisone in PMR NCT02702778 · started 2016 · scored riskier than 29% of active trials terminated
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) NCT05436652 · started 2022 · scored riskier than 22% of active trials completed
A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) NCT06281236 · started 2022 · scored riskier than 20% of active trials terminated
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica NCT03600818 · started 2018 · scored riskier than 50% of active trials terminated
Timed Release Tablet Prednisone in Polymyalgia Rheumatica NCT00836810 · started 2009 · scored riskier than 16% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.