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Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

NCT02535689 on ClinicalTrials.gov Phase 1 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (government) Started 2015-08-28 Completed
Riskier than 57% of active trials
this trial: 18% 0% 36%

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 13% of the time (651 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-04-26, after 2015-08-28 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

0% 19% 37% 56% 74% 0123456 yr completed 65% terminated 20%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-04-26. 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

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
1 (typical: 2)
Number of arms
3 (typical: 2)
Allocation
randomized
Design
parallel
Primary purpose
other (typical: treatment)
Blinding
quadruple (typical: none)
Has a data monitoring committee
not given (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
4 (typical: 1)

Who can join

Minimum age
18
Maximum age
100 (typical: 71)
Sex
all
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
government (typical: academic or other)
Sponsor's past trials
39 (typical: 32)
Sponsor's past termination rate
15.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
2 (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
7504 (typical: 2148)
Drug's FAERS reports in the prior 12 months
3853 (typical: 412.5)
Drug's FAERS reports marked serious
40.3% (typical: 85.6%)
Drug's FAERS reports with a death
2.6% (typical: 15.9%)

Disease area and drugs

Disease areas
immunology, dermatology
Drugs matched to FDA substances
tofacitinib

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

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.