Trial reportArthritis and rheumatism2009
Course of the modified Rodnan skin thickness score in systemic sclerosis clinical trials: analysis of three large multicenter, double-blind, randomized controlled trials.
Trial report in Arthritis and rheumatism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 129 citations in OpenAlex.
- Assessment of skin involvement in systemic sclerosis.Rheumatology (Oxford, England) · 2017Pooled it
- Twenty-two points to consider for clinical trials in systemic sclerosis, based on EULAR standards.Rheumatology (Oxford, England) · 2015Pooled it
- Role of circulating endothelial cells in assessing the severity of systemic sclerosis and predicting its clinical worsening.Scientific reports · 2021Trial
- A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.Annals of the rheumatic diseases · 2020Trial
- Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.Annals of the rheumatic diseases · 2020Trial
- Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator-Initiated, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.Arthritis & rheumatology (Hoboken, N.J.) · 2020Trial
- Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post Hoc Analyses From Two Randomized Placebo-Controlled Trials.Arthritis care & research · 2018Trial
- Nilotinib (Tasigna™) in the treatment of early diffuse systemic sclerosis: an open-label, pilot clinical trial.Arthritis research & therapy · 2015Trial
- Fresolimumab treatment decreases biomarkers and improves clinical symptoms in systemic sclerosis patients.The Journal of clinical investigation · 2015Trial
- A one-year, phase I/IIa, open-label pilot trial of imatinib mesylate in the treatment of systemic sclerosis-associated active interstitial lung disease.Arthritis and rheumatism · 2011Trial
- Imatinib mesylate (Gleevec) in the treatment of diffuse cutaneous systemic sclerosis: results of a 1-year, phase IIa, single-arm, open-label clinical trial.Annals of the rheumatic diseases · 2011Trial
- Tendon friction rubs in early diffuse systemic sclerosis: prevalence, characteristics and longitudinal changes in a randomized controlled trial.Rheumatology (Oxford, England) · 2010Trial
- Autoantibody associations in patients with early diffuse cutaneous systemic sclerosis: the prospective registry of early systemic sclerosis.Seminars in arthritis and rheumatism · 2026Article
- Evaluation of hand functional indices in association to clinical, laboratory, and radiologic data in patients with systemic sclerosis.Turkish journal of physical medicine and rehabilitation · 2026Article
- Re-envisioning clinical trial design in systemic sclerosis.Expert review of clinical immunology · 2025Review
- Elastography as a possible useful method of assessment of skin involvement in systemic sclerosis.Postepy dermatologii i alergologii · 2022Article
- Skin involvement in early diffuse cutaneous systemic sclerosis: an unmet clinical need.Nature reviews. Rheumatology · 2022Review
- Limited cutaneous systemic sclerosis: Total rehabilitation with fixed prosthesis on dental implants.Journal of scleroderma and related disorders · 2021Article
- A critical role of AREG for bleomycin-induced skin fibrosis.Cell & bioscience · 2021Article
- Treatment with cyclophosphamide i.v. pulse therapy is an option for effective treatment of skin fibrosis in patients with early systemic sclerosis.Rheumatology (Oxford, England) · 2020Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
objectiveTo assess the course of the modified Rodnan skin thickness score (MRSS) in 3 large, multicenter, double-blind, randomized controlled trials (RCTs) of patients with diffuse cutaneous systemic sclerosis (dcSSc) with different baseline disease durations, as defined from the date of onset of the first dcSSc symptom (excluding Raynaud's phenomenon) or from the date of onset of the first dcSSc-related symptom (including Raynaud's phenomenon).
methodsData from 3 RCTs examining high-dose versus low-dose D-penicillamine (D-Pen Trial), recombinant human relaxin versus placebo (Relaxin Trial), and oral bovine type I collagen versus placebo (Collagen Trial) treatment in patients with dcSSc were pooled and analyzed. Patients were divided into 5 groups according to their disease duration at baseline. The linear mixed model for correlated data was used to model the 2 predictors of MRSS: time in study (expressed in months after baseline) and baseline disease duration (expressed in months, calculated from the date of onset of the first symptom characteristic of dcSSc with and without Raynaud's phenomenon).
resultsAt study entry, the mean MRSS value was 21.0 in the D-Pen Trial cohort, 27.3 in the Relaxin Trial cohort, and 26.1 in the Collagen Trial cohort. Time in study was a significant predictor of improvement in MRSS regardless of the disease duration at baseline (P<0.0001). Patients with a disease duration of >or=24 months showed a greater rate of decline as compared with patients with a disease duration of <24 months (P<0.05). Similar results were obtained when disease duration was reclassified by including the time of the first Raynaud's phenomenon symptom in the definition.
conclusionOur study confirms recent findings that in patients entered into these 3 RCTs, skin thickening did not follow the same trend in natural history as that seen in the dcSSc populations entered into early, open longitudinal studies previously reported. These findings have important implications for study design, in which "prevention of worsening" is the main objective.
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.