Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-03-21, after 2015-10-16 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2018-03-21. 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) (raises risk) · Wording
Phrases that raised it: subjectsplacebomultipledouble blindbowel
Phrases that lowered it: and safetyefficacy andsafety ofopen labelevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past trials: 2171 (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 12.3% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 257 (raises risk) · Sponsor's track record
-
Number of arms: 6 (lowers risk) · Design
-
Drug's FAERS reports before start: 108307 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 72.0% (lowers risk) · Drug's FDA history
-
Minimum age: 50 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Maximum age: not given (lowers risk) · Who can join
-
Blinding: double (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Drug's FAERS reports in the prior 12 months: 23572 (lowers risk) · Drug's FDA history
-
Keywords listed: 1 (raises risk) · Design
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 2171 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 257 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 108307 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 23572 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, neurology, immunology, dermatology
- Drugs matched to FDA substances
- prednisone, sirukumab
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
- Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA NCT03600805 · started 2018 · scored riskier than 32% of active trials terminated
- A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis NCT03765788 · started 2019 · scored riskier than 95% of active trials completed
- An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) NCT01791153 · started 2013 · scored riskier than 49% of active trials completed
- Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission NCT05380453 · started 2022 · scored riskier than 72% of active trials completed
- A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis NCT04633447 · started 2020 · scored riskier than 77% of active trials terminated
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.