A Clinical Study With Adalimumab Biosimilar
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 0% 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 (776 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-20, after 2022-08-01 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 2023-10-20. 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: adequatepulmonary gastrointestinaldiseasesubjects withsubject
Phrases that lowered it: healthypharmacokineticthe investigatorsafetyarthritis -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Primary purpose: other (lowers risk) · Design
-
Drug's FAERS reports marked serious: 58.9% (lowers risk) · Drug's FDA history
-
Minimum age: 21 (lowers risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 3.8% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 38275 (raises risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Collaborators: 2 (lowers risk) · Design
-
Maximum age: 55 (lowers risk) · Who can join
-
Keywords listed: 17 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 17 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 391956 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 38275 (typical: 412.5)
- Drug's FAERS reports marked serious
- 58.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive, immunology, dermatology, musculoskeletal
- Drugs matched to FDA substances
- adalimumab
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
- Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS NCT04018599 · started 2019 · scored riskier than 2% of active trials completed
- A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety NCT01712178 · started 2012 · scored riskier than 30% of active trials completed
- Adalimumab Microneedles in Healthy Volunteers NCT03607903 · started 2018 · scored riskier than 4% of active trials completed
- Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers NCT03579823 · started 2018 · scored riskier than 3% of active trials completed
- Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants NCT05995691 · started 2014 · scored riskier than 3% 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.