Evidence map›Paper›PMID 24919980›Full record

Trial reportThrombosis and haemostasis2014

Rituximab for treatment of inhibitors in haemophilia A. A Phase II study.

C Leissinger, C D Josephson, S Granger, B A Konkle, R Kruse-Jarres, M V Ragni, J M Journeycake, L Valentino, N S Key, J C Gill and 9 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Thrombosis and haemostasis, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 43 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Immunogenicity of TNF-Inhibitors.Frontiers in immunology · 2020
    Review
  6. Article
  7. Article
  8. Gene therapy for hemophilia: what does the future hold?Therapeutic advances in hematology · 2018
    Review
  9. Review
  10. [Advances in Hemophilia A inhibitors].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2017
    Article
  11. Article
  12. 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

19 authors at 14 institutions in 1 country.

C Leissinger
C D Josephson
S GrangerSuzanne Granger, MS, New England Research Institutes, Inc., 480 Pleasant St., Watertown, MA 02472, USA, Tel.: +1 617 972 3319, Fax: +1 617 926 8246, E-mail: SGranger@neriscience.com.
B A Konkle
R Kruse-Jarres
M V Ragni
J M Journeycake
L Valentino
N S Key
J C Gill
K R McCrae
E J Neufeld
C Manno
L Raffini
K Saxena
M Torres
V Marder
C M Bennett
S F Assmann
Emory University · USNew England Research Institutes · USTulane University · USBloodworks Northwest · USCleveland Clinic · USCook Children's Medical Center · USHarvard University Press · USMedical College of Wisconsin · USNew York University · USOrthopaedic Hospital · USRush University · USThe University of Texas Southwestern Medical Center · USUniversity of Oklahoma · USUniversity of Pittsburgh · US

Funding

Transfusion Medicine/Hemostasis Research Network: DCCU01HL072268 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI ASSMANN, SUSAN FERA · 2002 to 2012
$33.2M
Transfusion Medicine/Hemostasis Clinical Trials NetworkU01HL072291 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI NEUFELD, ELLIS J · 2002 to 2011
$2.6M
Oklahoma-UT Southwestern Hemostasis ConsortiumU01HL072283 · NHLBI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI GEORGE, JAMES N · 2002 to 2013
$2.6M
Transfusion Medicine/Hemostasis Clinical Trails NetworkU01HL072248 · NHLBI · EMORY UNIVERSITY · PI JOSEPHSON, CASSANDRA D · 2002 to 2012
$2.4M
Hemostasis Clinical Research Network ProtocolsU01HL072274 · NHLBI · TULANE UNIVERSITY OF LOUISIANA · PI LEISSINGER, CINDY A · 2002 to 2012
$2.2M
Transfusion Medicine/Hemostasis Clinical Trials NetworkU01HL072355 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KEY, NIGEL · 2002 to 2012
$2.1M
Transfusion/Hemostasis Clinical Research NetworkU01HL072346 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI SACHAIS, BRUCE · 2002 to 2012
$2.1M
TMH Clinical Trials Network-Wisconsin Core Clinical CenterU01HL072290 · NHLBI · VERSITI WISCONSIN, INC. · PI MC FARLAND, JANICE G · 2002 to 2012
$2.1M
Transfusion Medicine/Hemostasis Clinical Research NetworkU01HL072331 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI TRIULZI, DARRELL J · 2002 to 2012
$2.0M
Transfusion Medicine/Hemostasis Clinical Research NetworkU01HL072033 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI MCCRAE, KEITH R. · 2002 to 2012
$1.7M
NHLBI NIH HHS HL072033NHLBI NIH HHS HL072248NHLBI NIH HHS HL072268NHLBI NIH HHS HL072274NHLBI NIH HHS HL072283NHLBI NIH HHS HL072290NHLBI NIH HHS HL072291NHLBI NIH HHS HL072331NHLBI NIH HHS HL072346NHLBI NIH HHS HL072355NHLBI NIH HHS U01 HL072033NHLBI NIH HHS U01 HL072248NHLBI NIH HHS U01 HL072268NHLBI NIH HHS U01 HL072274NHLBI NIH HHS U01 HL072283NHLBI NIH HHS U01 HL072290NHLBI NIH HHS U01 HL072291NHLBI NIH HHS U01 HL072331NHLBI NIH HHS U01 HL072346NHLBI NIH HHS U01 HL072355
6 · The paper itself

Abstract

The development of antibodies against infused factor VIII (FVIII) in patients with haemophilia A is a serious complication leading to poorly controlled bleeding and increased morbidity. No treatment has been proven to reduce high titre antibodies in patients who fail immune tolerance induction or are not candidates for it. The Rituximab for the Treatment of Inhibitors in Congenital Hemophilia A (RICH) study was a phase II trial to assess whether rituximab can reduce anamnestic FVIII antibody (inhibitor) titres. Male subjects with severe congenital haemophilia A and an inhibitor titre ≥5 Bethesda Units/ml (BU) following a FVIII challenge infusion received rituximab 375 mg/m² weekly for weeks 1 through 4. Post-rituximab inhibitor titres were measured monthly from week 6 through week 22 to assess treatment response. Of 16 subjects who received at least one dose of rituximab, three (18.8%) met the criteria for a major response, defined as a fall in inhibitor titre to <5 BU, persisting after FVIII re-challenge. One subject had a minor response, defined as a fall in inhibitor titre to <5 BU, increasing to 5-10 BU after FVIII re-challenge, but <50% of the original peak inhibitor titre. Rituximab is useful in lowering inhibitor levels in patients, but its effect as a solo treatment strategy is modest. Future studies are indicated to determine the role of rituximab as an adjunctive therapy in immune tolerisation strategies.

Indexed as

AdolescentAdultAntibodies, BlockingAntibodies, Monoclonal, Murine-DerivedAntibody FormationAntigens, CD20Blood CoagulationChildChild, PreschoolFactor VIIIFollow-Up StudiesHemophilia AHumansImmunosuppressive AgentsMaleRituximabAntibodies, BlockingAntibodies, Monoclonal, Murine-DerivedAntigens, CD20Factor VIIIImmunosuppressive AgentsRituximabantibodiesAnti-CD20blood coagulation inhibitorCD20 antibodyhaemophilia Amonoclonalmurine-derived

Identifiers

PMID24919980
PMCPMC5726888
OpenAlexW1838398103

What OpenQuestion holds

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Registered trials

None linked

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.