Evidence map›Paper›PMID 23653652›Full record

ArticleInternational journal of rheumatology2013

Design of the tocilizumab in giant cell arteritis trial.

Sebastian H Unizony, Bhaskar Dasgupta, Elena Fisheleva, Lucy Rowell, Georg Schett, Robert Spiera, Jochen Zwerina, Olivier Harari, John H Stone

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in International journal of rheumatology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812302 (Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
10.4field-weighted citation impact, top 1% 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.

NCT03812302 phase2completednot on this mapstarted 2019, after this paper: background citation

Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)

TypeinterventionalSponsorUniversity of AlbertaRan2019 to 2023Enrolled9ConditionsGiant Cell ArteritisArms68-Ga HA-DOTATATE PET/CT
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 118 citations in OpenAlex.

  1. Aspirin as adjunctive treatment for giant cell arteritis.The Cochrane database of systematic reviews · 2014
    Pooled it
  2. Pooled it
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  4. Treatment failure in giant cell arteritis.Annals of the rheumatic diseases · 2021
    Trial
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  9. Article
  10. Review
  11. Comparison of [EJNMMI reports · 2025
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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

9 authors at 5 institutions in 3 countries.

Sebastian H UnizonyMassachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.
Bhaskar Dasgupta
Elena Fisheleva
Lucy Rowell
Georg Schett
Robert Spiera
Jochen Zwerina
Olivier Harari
John H Stone
Roche (United Kingdom) · GBFriedrich-Alexander-Universität Erlangen-Nürnberg · DEHarvard University · USHospital for Special Surgery · USSouthend Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Overview. The GiACTA trial is a multicenter, randomized, double-blind, and placebo-controlled study designed to test the ability of tocilizumab (TCZ), an interleukin (IL)-6 receptor antagonist, to maintain disease remission in patients with giant cell arteritis (GCA). Design. Approximately 100 centers will enroll 250 patients with active disease. The trial consists of a 52-week blinded treatment phase followed by 104 weeks of open-label extension. Patients will be randomized into one of four groups. Group A (TCZ 162 mg weekly plus a 6-month prednisone-taper); group B (TCZ 162 mg every other week plus a 6-month prednisone-taper); group C (placebo plus a 6-month prednisone-taper); and group D (placebo plus a 12-month prednisone taper). We hypothesize that patients assigned to TCZ in addition to a 6-month prednisone course are more likely to achieve the primary efficacy endpoint of sustained remission (SR) at 52 weeks compared with those assigned to a 6-month prednisone course alone, thus potentially minimizing the long-term adverse effects of corticosteroids. Conclusion. GiACTA will test the hypothesis that interference with IL-6 signaling exerts a beneficial effect on patients with GCA. The objective of this paper is to describe the design of the trial and address major issues related to its development.

Identifiers

PMID23653652
PMCPMC3638687
OpenAlexW2098959715

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.