Evidence map›Paper›PMID 28601821›Full record

Trial reportBMJ open2017

Study protocol: COmparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis (CONSUL) - an open-label randomized controlled multicenter trial.

Fabian Proft, Burkhard Muche, Joachim Listing, Valeria Rios-Rodriguez, Joachim Sieper, Denis Poddubnyy

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02758782 (COmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT02758782 phase4completednot on this map

COmparison of the Effect of Treatment With NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of StrUctural Damage in the Spine Over Two Years in Patients With ankyLosing Spondylitis: a Randomized Controlled Multicentre Trial

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2016 to 2021Enrolled156ConditionsAnkylosing SpondylitisArmsGolimumab, Celecoxib
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Bone Involvement in Patients with Spondyloarthropathies.Calcified tissue international · 2022
    Review
  10. A glance into the future of diagnosis and treatment of spondyloarthritis.Therapeutic advances in musculoskeletal disease · 2022
    Review
  11. Article
  12. Current Unmet Needs in Spondyloarthritis.Current rheumatology reports · 2019
    Review
  13. 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

6 authors at 3 institutions in 2 countries.

Fabian ProftDepartment of Gastroenterology, Infectiology and Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Burkhard MucheDepartment of Gastroenterology, Infectiology and Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Joachim ListingDepartment of Epidemiology, German Rheumatism Research Centre, Berlin, Germany.
Valeria Rios-RodriguezDepartment of Gastroenterology, Infectiology and Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Joachim SieperDepartment of Gastroenterology, Infectiology and Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Denis PoddubnyyDepartment of Gastroenterology, Infectiology and Rheumatology, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Charité - Universitätsmedizin Berlin · DEFranklin University · USGerman Rheumatism Research Centre · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere is some evidence that non-steroidal anti-inflammatory drugs (NSAIDs), in particular celecoxib, might possess not only a symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS), retarding the progression of structural damage in the spine if taken continuously. In contrast, this remains controversial for tumour necrosis factor alpha (TNF-α) inhibitors, despite their good clinical efficacy. The impact of a combined therapy (a TNF inhibitor plus an NSAID) on radiographic spinal progression in AS is unclear. METHODS AND ANALYSIS: The aim of this study is to evaluate the impact of treatment with an NSAID (celecoxib) when added to a TNF inhibitor (golimumab) compared with TNF inhibitor (golimumab) alone on progression of structural damage in the spine over 2 years in patients with AS. The study consists of a 6-week screening period, a 12-week period (phase I: run-in phase) of treatment with golimumab for all subjects followed by a 96-week controlled treatment period (phase II: core phase) with golimumab plus celecoxib versus golimumab alone, and a safety follow-up period of 4 weeks. At week 108, the primary study endpoint radiographic spinal progression (as assessed by the change in the modified Stoke Ankylosing Spondylitis Spine Score after 2 years) will be evaluated. ETHICS AND DISSEMINATION: The study will be performed according to the principles of good clinical practice and the German drug law. The written approval of the independent ethics committee and of the German federal authority have been obtained. On study completion, results are expected to be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov register (NCT02758782) and European Union Clinical Trials Register (EudraCT No 2016-000615-33).

Indexed as

AdultAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalCelecoxibDisease ProgressionDrug Therapy, CombinationFemaleHumansImmunologic FactorsMaleMiddle AgedSpondylitis, AnkylosingTumor Necrosis Factor-alphaAntibodies, MonoclonalAnti-Inflammatory Agents, Non-SteroidalCelecoxibgolimumabImmunologic FactorsTumor Necrosis Factor-alphaAnkylosing spondylitismSASSNSAIDsradiographic progressionTNF inhibitors

Identifiers

PMID28601821
PMCPMC5623356
OpenAlexW2622873710

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.