Evidence map›Paper›PMID 12228157›Full record

Trial reportAnnals of the rheumatic diseases2002

Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion.

M J Leandro, J C W Edwards, G Cambridge

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 78 papers.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed
–field-weighted citation impact
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.

NCT00261118 phase2 / phase3completednot on this mapstarted 2004, after this paper: background citation

Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis

TypeinterventionalSponsorRoyal Liverpool University HospitalRan2004 to 2009Enrolled24ConditionsUlcerative ColitisArmsRituximab
NCT00286325 phase1 / phase2completednot on this mapstarted 2005, after this paper: background citation

Rituximab in the Treatment of Patients With Bullous Pemphigoid

TypeinterventionalSponsorDuke UniversityRan2005 to 2010Enrolled8ConditionsBullous PemphigoidArmsRituximab
3 · Its place in the literature

Who cites it

78 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Reactivation of latent viruses in individuals receiving rituximab for new onset type 1 diabetes.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2013
    Trial
  4. Trial
  5. Rituximab for refractory Wegener's granulomatosis: report of a prospective, open-label pilot trial.American journal of respiratory and critical care medicine · 2006
    Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Autoimmunity: the neoantigen hypothesis.Frontiers in immunology · 2024
    Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

M J LeandroCentre for Rheumatology, University College London, UK.
J C W Edwards
G Cambridge

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo obtain evidence for dose response and to extend evidence of safety and efficacy for B lymphocyte depletion in rheumatoid arthritis.

methodsTwenty two patients with rheumatoid arthritis received a total of 29 treatments with five different combinations of rituximab (RTX), cyclophosphamide (CP), and/or high dose prednisolone (PR) on an open basis as follows; cohort I: RTX 1400 mg/m(2), CP 750x2+PR; cohort II: RTX 300-700 mg/m(2), -CP+/-PR); cohort III: RTX 600-700 mg/m(2), CP 750x2+PR; cohort IV: RTX 1200 mg/m(2), CP 750x2-PR; cohort V: RTX 500 mg/m(2), CP 750x2+PR. American College of Rheumatology (ACR) criteria of improvement at six months were chosen as the primary outcome measure. Disease activity scores and total duration of improvement and of B cytopenia were also recorded.

resultsNo major adverse events attributable to treatment were seen. ACR grades of improvement at six months were as follows: cohort I: ACR70x3, ACR50x2; cohort II: ACR20x1, ACR0x3; cohort III: ACR70x6, ACR50x2, ACR20x2; cohort IV: ACR70x2, ACR50x2, ACR20x1, ACR0x1; cohort V: ACR0x4.

conclusionsB lymphocyte depletion in rheumatoid arthritis has so far proved to be safe and associated with major improvement with protocols including RTX 600 mg/m(2) or more and CP, but not with more limited protocols. These observations provide an initial basis for the design of formal trials of B cell depletion and other B cell directed treatments, including a phase II controlled trial now in progress.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsArthritis, RheumatoidB-LymphocytesCombined Modality TherapyCyclophosphamideDrug Administration ScheduleDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLymphocyte DepletionAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedAntirheumatic AgentsCyclophosphamidePrednisoloneRituximab

Identifiers

PMID12228157
PMCPMC1753912

What OpenQuestion holds

Textmetadata
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.