Trial reportRheumatology (Oxford, England)2012
A randomized placebo-controlled trial of methotrexate in psoriatic arthritis.
Trial report in Rheumatology (Oxford, England), 2012. 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 115 papers, 12 of them syntheses that pooled 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.
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.
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial
Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis
Who cites it
115 citing papers in PubMed, 12 syntheses or guidelines pooled it, 321 citations in OpenAlex.
- Blood-test monitoring strategies for patients established on immune-suppressing drugs: a mixed-methods study.Health technology assessment (Winchester, England) · 2026Pooled it
- Guideline
- Evaluating the efficacy of biologics with and without methotrexate in the treatment of psoriatic arthritis: a network meta-analysis.RMD open · 2024Pooled it
- Management of particular clinical situations in psoriatic arthritis: an expert's recommendation document based on systematic literature review and extended Delphi process.Rheumatology international · 2021Pooled it
- EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update.Annals of the rheumatic diseases · 2020Guideline
- Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals.Rheumatology international · 2019Pooled it
- Methotrexate for psoriatic arthritis.The Cochrane database of systematic reviews · 2019Pooled it
- Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2019Guideline
- Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.Arthritis care & research · 2019Guideline
- Indirect comparisons of the efficacy of subsequent biological agents in patients with psoriatic arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis.Clinical rheumatology · 2016Pooled it
- Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials.PloS one · 2016Pooled it
- Methotrexate use and risk of lung disease in psoriasis, psoriatic arthritis, and inflammatory bowel disease: systematic literature review and meta-analysis of randomised controlled trials.BMJ (Clinical research ed.) · 2015Pooled it
- Methotrexate and Prednisolone compared to placebo and prednisolone in the treatment of severe Erythema Nodosum Leprosum: An international multicentre, double-blind randomised controlled clinical trial-MaPs in ENL.PLoS neglected tropical diseases · 2026Trial
- Comparison between methotrexate and apremilast in Psoriatic Arthritis-a single blind randomized controlled trial (APREMEPsA study).Rheumatology international · 2023Trial
- Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials.Clinical rheumatology · 2022Trial
- Efficacy of secukinumab and adalimumab in patients with psoriatic arthritis and concomitant moderate-to-severe plaque psoriasis: results from EXCEED, a randomized, double-blind head-to-head monotherapy study.The British journal of dermatology · 2021Trial
- Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies.Arthritis research & therapy · 2021Trial
- Trial
- Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.Annals of internal medicine · 2020Trial
- Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2019Trial
55 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
Authors and funding
13 authors at 3 institutions in 2 countries.
Funding
Abstract
objectiveMTX is widely used to treat synovitis in PsA without supporting trial evidence. The aim of our study was to test the value of MTX in the first large randomized placebo-controlled trial (RCT) in PsA.
methodsA 6-month double-blind RCT compared MTX (15 mg/week) with placebo in active PsA. The primary outcome was PsA response criteria (PsARC). Other outcomes included ACR20, DAS-28 and their individual components. Missing data were imputed using multiple imputation methods. Treatments were compared using logistic regression analysis (adjusted for age, sex, disease duration and, where appropriate, individual baseline scores).
resultsFour hundred and sixty-two patients were screened and 221 recruited. One hundred and nine patients received MTX and 112 received placebo. Forty-four patients were lost to follow-up (21 MTX, 23 placebo). Twenty-six patients discontinued treatment (14 MTX, 12 placebo). Comparing MTX with placebo in all randomized patients at 6 months showed no significant effect on PsARC [odds ratio (OR) 1.77, 95% CI 0.97, 3.23], ACR20 (OR 2.00, 95% CI 0.65, 6.22) or DAS-28 (OR 1.70, 95% CI 0.90, 3.17). There were also no significant treatment effects on tender and swollen joint counts, ESR, CRP, HAQ and pain. The only benefits of MTX were reductions in patient and assessor global scores and skin scores at 6 months (P = 0.03, P < 0.001 and P = 0.02, respectively). There were no unexpected adverse events.
conclusionsThis trial of active PsA found no evidence for MTX improving synovitis and consequently raises questions about its classification as a disease-modifying drug in PsA. Trial registration. Current Controlled Trials, www.controlled-trials.com, ISRCTN:54376151.
Indexed as
Identifiers
What OpenQuestion holds
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.