A Study of Guselkumab in Participants With Systemic Sclerosis
Model scores of the 29,894 trials active now.
Model score 16% 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 (240 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-07-09, after 2021-02-24 start.
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 2024-07-09. 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: sclerosispulmonaryfibrosisscreeningplacebo controlled
Phrases that lowered it: participantsparticipantbodyareaevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports marked serious: 30.9% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 1.6% (lowers risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 13 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Collaborators: 0 (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
- 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
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 95 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 13 (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
- 5738 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2223 (typical: 412.5)
- Drug's FAERS reports marked serious
- 30.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology
- Drugs matched to FDA substances
- guselkumab
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
- A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis NCT04744207 · started 2020 · scored riskier than 14% of active trials completed
- Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis NCT01670565 · started 2012 · scored riskier than 96% of active trials completed
- Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis NCT02921971 · started 2016 · scored riskier than 85% of active trials completed
- Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis NCT03398837 · started 2017 · scored riskier than 37% of active trials terminated
- Proof of Biological Activity of SAR100842 in Systemic Sclerosis NCT01651143 · started 2013 · scored riskier than 77% 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.