Evidence map›Paper›PMID 23278574›Full record

Trial reportAnnals of the New York Academy of Sciences2012

Phase II trial of methotrexate in myasthenia gravis.

Mamatha Pasnoor, Jianghua He, Laura Herbelin, Mazen Dimachkie, Richard J Barohn, Muscle Study Group

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Annals of the New York Academy of Sciences, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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 1 institution in 1 country.

Mamatha PasnoorUniversity of Kansas Medical Center, Kansas City, Kansas, USA. mpasnoor@kumc.edu
Jianghua He
Laura Herbelin
Mazen Dimachkie
Richard J Barohn
Muscle Study Group
University of Kansas Medical Center · US

Funding

Heartland Institute for Clinical and Translational ResearchUL1TR000001 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2012 to 2015
$13.0M
HEARTLAND INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCHUL1RR033179 · NCRR · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2011 to 2011
$3.2M
Phase II Trial of methotrexate in myasthenia gravis FDA IND#:101,306 01/06/2008R01FD003538 · FDA · UNIVERSITY OF KANSAS MEDICAL CENTER · PI BAROHN, RICHARD J. · 2009 to 2012
$1.6M
FDA HHS R01 FD 003538FDA HHS R01 FD003538NCATS NIH HHS UL1 TR 000001NCATS NIH HHS UL1 TR000001NCRR NIH HHS UL1 RR 033179NCRR NIH HHS UL1 RR033179
6 · The paper itself

Abstract

Prednisone is a frequently used treatment for myasthenia gravis (MG) but it has numerous side effects. Methotrexate is a selective inhibitor of dihydrofolate reductase and lymphocyte proliferation and is an effective immuosuppressive medication for autoimmune diseases. Given the negative results of the mycophenolate mofetil study, search for an effective immunosuppressant drug therapy is ongoing. The objective is to determine if oral methotrexate is safe and effective for MG patients who take prednisone. We have initiated a randomized, double-blind, placebo-controlled multicenter trial of methotrexate versus placebo in patients taking at least 10 mg/day of prednisone at enrollment. The methotrexate dose is increased to 20 mg and the prednisone dose is adjusted per protocol during the study. Clinical and laboratory evaluations are performed monthly for 12 months, with the primary efficacy measure being the nine-month prednisone area under the curve (AUC) from months 3 to 12. Secondary outcome measures include MG outcomes, quality of life measures, and a polyglutamation biomarker assay. A total of 18 U.S. sites and 2 Canadian sites are participating, with 48 screened cases, 42 enrolled, with 19 still active in the study.

Indexed as

Double-Blind MethodHumansImmunosuppressive AgentsMethotrexateMyasthenia GravisPlacebosQuality of LifeImmunosuppressive AgentsMethotrexatePlacebos

Identifiers

PMID23278574
PMCPMC3564221
OpenAlexW1765269564

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.