Evidence map›Paper›PMID 29106053›Full record

Trial reportClinical and translational science2018

Population Pharmacokinetics of Fosdagrocorat (PF-04171327), a Dissociated Glucocorticoid Receptor Agonist, in Patients With Rheumatoid Arthritis.

Barry Weatherley, Lynn McFadyen, Brinda Tammara

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01393639 (A PHASE 2, RANDOMIZED, DOUBLE BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF 04171327), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01393639 phase2completednot on this map

A phase 2, randomized, double blind assessment of efficacy and safety of pf 04171327(1, 5, 10, 15 mg dose, daily) compared to 5 mg and 10 mg prednisone daily and placebo daily in subjects with rheumatoid arthritis over an 8 week period followed by a 4 week period of tapering of study drug.

TypeinterventionalSponsorPfizerRan2011 to 2014Enrolled323ConditionsRheumatoid ArthritisArmsPF-04171327, prednisone, placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. In Silico Repurposed Drugs against Monkeypox Virus.Molecules (Basel, Switzerland) · 2022
    Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 2 countries.

Barry WeatherleyPharmacometrics, Pfizer Global Product Development, Sandwich, Kent, UK.
Lynn McFadyenPharmacometrics, Pfizer Global Product Development, Sandwich, Kent, UK.
Brinda TammaraClinical Pharmacology, Pfizer Inc., Collegeville, Pennsylvania, USA.
Pfizer (United Kingdom) · GBPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Dissociated agonists of the glucocorticoid receptor (DAGRs) show similar antiinflammatory effects but improved tolerability compared with standard glucocorticoid receptor (GR) agonists. The prodrug fosdagrocorat (PF-04171327), with active DAGR metabolite PF-00251802 (Metabolite-1), is postulated to show superior efficacy over placebo and prednisone in patients with moderate to severe rheumatoid arthritis (RA). We investigated the population pharmacokinetics of active Metabolite-1 and its active metabolite PF-04015475 (Metabolite-2) in patients with moderate to severe RA enrolled in a 12-week, phase II, randomized, double-blind study (NCT01393639). A simultaneous fit of a two-compartment model for Metabolite-1 and a one-compartment model for Metabolite-2 provided an adequate fit to the data. Significant covariates included weight, with an additional female effect on clearance of Metabolite-1 (∼26%) and Metabolite-2 (∼33%) compared with males. Age influenced clearance of Metabolite-1. In combination, age, weight, and sex predicted >twofold differences in area under the concentration-time curve of Metabolite-1 at the extremes.

Indexed as

Biological Variation, PopulationAdministration, OralAdultAgedAged, 80 and overAge FactorsArea Under CurveArthritis, RheumatoidBenzamidesBody WeightDose-Response Relationship, DrugDouble-Blind MethodFemaleGlucocorticoidsHumansMaleBenzamidesfosdagrocoratGlucocorticoidsOrganophosphatesPhenanthrenesPrednisoneProdrugsReceptors, Glucocorticoid

Identifiers

PMID29106053
PMCPMC5759734
OpenAlexW2765282147

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.