Trial reportArthritis and rheumatism2008
A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease.
Trial report in Arthritis and rheumatism, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01199887 (A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis), which is not on this map. Cited by 42 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.
A Phase One, Open Label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Biologic Effects of Three Doses of IW001 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Efficacy and safety of hydrolyzed collagen supplementation on skin health outcomes: a systematic literature review of randomized controlled trials.European journal of clinical nutrition · 2026Pooled it
- Assessment of skin involvement in systemic sclerosis.Rheumatology (Oxford, England) · 2017Pooled it
- Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial.Annals of the rheumatic diseases · 2020Trial
- Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial.Annals of the rheumatic diseases · 2014Trial
- Sensitivity to change of the modified Rodnan skin score in diffuse systemic sclerosis--assessment of individual body sites in two large randomized controlled trials.Rheumatology (Oxford, England) · 2009Trial
- Course of the modified Rodnan skin thickness score in systemic sclerosis clinical trials: analysis of three large multicenter, double-blind, randomized controlled trials.Arthritis and rheumatism · 2009Trial
- Differences in presentation of younger and older systemic sclerosis patients in clinical trials.Clinical and experimental rheumatologyTrial
- A programmable arthritis-specific receptor for guided articular cartilage regenerative medicine.Osteoarthritis and cartilage · 2025Article
- EMID2 is a novel biotherapeutic for aggressive cancers identified by in vivo screening.Journal of experimental & clinical cancer research : CR · 2024Article
- Homogeneity test of relative risk ratios for stratified bilateral data under different algorithms.Journal of applied statistics · 2023Article
- Review
- Clinical Treatment Options in Scleroderma: Recommendations and Comprehensive Review.Clinical reviews in allergy & immunology · 2022Review
- Defining the optimal disease duration of early diffuse systemic sclerosis for clinical trial design.Rheumatology (Oxford, England) · 2021Observational
- Multithreshold change plane model: Estimation theory and applications in subgroup identification.Statistics in medicine · 2021Article
- Ultrasound Surface Wave Elastography for Assessing Scleroderma.Ultrasound in medicine & biology · 2020Article
- High burden of skin sclerosis is associated with severe organ involvement in patients with systemic sclerosis and systemic sclerosis overlap syndrome.Rheumatology international · 2018Observational
- Forkhead box protein 3 demethylation is associated with tolerance induction in peanut-induced intestinal allergy.The Journal of allergy and clinical immunology · 2018Article
- An Ultrasound Surface Wave Technique for Assessing Skin and Lung Diseases.Ultrasound in medicine & biology · 2018Article
- Unraveling SSc Pathophysiology; The Myofibroblast.Frontiers in immunology · 2018Review
- Monomeric, porous type II collagen scaffolds promote chondrogenic differentiation of human bone marrow mesenchymal stem cells in vitro.Scientific reports · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 13 institutions in 1 country.
Funding
Abstract
objectiveTo investigate the safety and efficacy of oral bovine type I collagen (CI) treatment in patients who have had diffuse cutaneous systemic sclerosis (dcSSc; scleroderma) for <or=10 years.
methodsOne hundred sixty-eight patients with dcSSc were enrolled in a double-blind, placebo-controlled trial of oral CI (500 microg/day) or placebo administered over 12 months, with a followup visit at month 15. The primary outcome was the modified Rodnan skin thickness score (MRSS). Other clinical and immune system parameters were also assessed.
resultsIntent-to-treat and modified intent-to-treat analyses showed that for the total population of patients with dcSSc, there were no significant differences in the mean change in MRSS or other key clinical parameters between the CI and placebo treatment groups at 12 months or at 15 months. However, in a subanalysis of the available data at month 15, the CI-treated group of patients with late-phase dcSSc experienced a significant reduction in the MRSS compared with that in the placebo-treated patients with late-phase dcSSc (change in MRSS at month 15 -7.9 versus -2.9; P = 0.0063).
conclusionAlthough the results from this trial did not meet the primary outcome goals, the findings from exploratory analyses indicated that CI treatment may benefit patients with late-phase dcSSc. This new treatment strategy and preliminary clinical observations in patients with dcSSc need to be corroborated.
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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.