A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% 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 2016-07-04, after 2015-04-28 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-07-04. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: dldefinedulnsubjectaminotransferase
Phrases that lowered it: drugsefficacyoralpharmacokineticssafety -
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports marked serious: 30.5% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Maximum age: 99 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 79 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.5% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 33 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers 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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (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
- 18
- Maximum age
- 99 (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
- 33 (typical: 32)
- Sponsor's past termination rate
- 6.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 79 (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
- 50824 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 47654 (typical: 412.5)
- Drug's FAERS reports marked serious
- 30.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology, musculoskeletal
- Drugs matched to FDA substances
- adalimumab, remtolumab
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 the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate NCT02141997 · started 2014 · scored riskier than 22% of active trials completed
- A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone NCT02066389 · started 2014 · scored riskier than 28% of active trials completed
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) NCT03104400 · started 2017 · scored riskier than 12% of active trials completed
- A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate NCT01554696 · started 2012 · scored riskier than 48% of active trials completed
- Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis NCT01999192 · started 2013 · scored riskier than 18% 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.