scholarly journals 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

2008 ◽  
Vol 58 (6) ◽  
pp. 1810-1822 ◽  
Author(s):  
Arnold E. Postlethwaite ◽  
Weng Kee Wong ◽  
Philip Clements ◽  
Soumya Chatterjee ◽  
Barri J. Fessler ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Type I Collagen ◽  
Controlled Trial ◽  
Late Phase ◽  
Type I ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Collagen Treatment

Su.106. Clinical Effects of Intraarticular Injection of Polymerized-Type I Collagen: a Double-Blind, Randomized, Placebo-Controlled Trial

2006 ◽  
Vol 119 ◽  
pp. S196
Author(s):  
Janette Furuzawa-Carballeda ◽  
Andres Agualimpia-Janning ◽  
Olga Munoz-Chable ◽  
Salvador Macias-Hernandez
Keyword(s):  
Type I Collagen ◽  
Controlled Trial ◽  
Intraarticular Injection ◽  
Type I ◽  
Clinical Effects ◽  
Double Blind

scholarly journals Abatacept in Early Diffuse Cutaneous Systemic Sclerosis: Results of a Phase II Investigator‐Initiated, Multicenter, Double‐Blind, Randomized, Placebo‐Controlled Trial

2019 ◽  
Vol 72 (1) ◽  
pp. 125-136 ◽  
Author(s):  
Dinesh Khanna ◽  
Cathie Spino ◽  
Sindhu Johnson ◽  
Lorinda Chung ◽  
Michael L. Whitfield ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Phase Ii ◽  
Controlled Trial ◽  
Double Blind ◽  
Diffuse Cutaneous Systemic Sclerosis

scholarly journals Coated-tube radioimmunoassay for C-telopeptides of type I collagen to assess bone resorption

1996 ◽  
Vol 42 (10) ◽  
pp. 1639-1644 ◽  
Author(s):  
M Bonde ◽  
C Fledelius ◽  
P Qvist ◽  
C Christiansen
Keyword(s):  
Bone Resorption ◽  
Postmenopausal Women ◽  
Type I Collagen ◽  
Premenopausal Women ◽  
Type I ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Analytical Recovery ◽  
Controlled Clinical Study ◽  
Different Doses

Abstract We present a coated-tube RIA that is useful for assessment of bone resorption. The assay uses a monoclonal antibody raised against a linear 8-amino-acid sequence (EKAHDGGR) derived from the C-telopeptides of type I collagen. Within-run and total CVs were 4.4% and 5.3-6.2%, respectively, at concentrations of 1-7 mg/L (n = 4-20). Analytical recovery was 98% +/- 8% and dilution 97% +/- 7%. Values obtained in a group of 36 premenopausal women were 227 +/- 89.6 mg/mol creatinine. In a group of 141 postmenopausal women, the values obtained were 429 +/- 225 mg/mol creatinine, a highly significant increase of 89% (P <0.001) over the premenopausal value. In a double-blind placebo-controlled clinical study of these postmenopausal women receiving five different doses of a bisphosphonate, a significant decrease of RIA-measured C-telopeptide values was seen in all bisphosphonate-treated groups, after just 3 months. Values in urine samples from postmenopausal women assayed with the RIA (gamma) and the CrossLaps(TM) ELISA (x) agreed well: slope = 0.98 (95% confidence interval, 0.94-1.01), intercept = 0.34 (0.25-0.43) mg/L, and Sylx = 0.93 mg/L (n = 678). We conclude that this RIA represents a valuable tool for assessing bone resorption.

Late Phase Inflammation during Nasal Grass and Ragweed Challenge in a Double-Blind Placebo Controlled Trial with Astemizole

1995 ◽  
Vol 9 (3) ◽  
pp. 169-174 ◽  
Author(s):  
Marianne Frieri ◽  
James Madden ◽  
Myron Zitt ◽  
Nanjundaiah S. Kumar ◽  
Maria Knapik
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Interleukin 1 ◽  
Late Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Anti Inflammatory

Allergic rhinitis is an IgE-mediated inflammatory reaction characterized by an early “classic” immediate hypersensitivity response and/or a subsequent late phase response. Nasal provocation to antigen challenge is a useful method of evaluating this dual response. Several H1 antagonists may exhibit antiinflammatory properties by diminishing histamine release or inhibiting eosinophil chemotaxis. To determine whether astemizole has any anti-inflammatory characteristics, we studied 20 patients with allergic rhinitis in a double-blind placebo-controlled fashion after a 4-week course of treatment with this H1 antagonist. Nasal provocation over 30 minutes was performed out of season using increasing concentrations of grass or ragweed extract from 10–1000 PNU. Patients were evaluated for their clinical response, and nasal lavage secretions were analyzed over 6 hours by ELISA for alpha interleukin-1, interleukin-8, albumin, and histamine levels. Total sneezing and other symptom scores for rhinorrhea, nasal congestion, and pruritus were decreased in astemizole-treated compared to placebo-treated patients both at 30 minutes (early phase), and at 3 and 6 hours (late phase) after nasal provocation. However, these results did not reach statistical significance. Nasal α IL-1 levels diminished from diluent control lavage to a significantly greater degree in astemizole than in placebo-treated patients (P < 0.05). This diminution in late phase α IL-1 suggests that astemizole may possess anti-inflammatory properties.

scholarly journals Intravenous Immunoglobulin May Be an Effective Therapy for Refractory, Active Diffuse Cutaneous Systemic Sclerosis

2014 ◽  
Vol 42 (2) ◽  
pp. 236-242 ◽  
Author(s):  
Corrie L. Poelman ◽  
Laura K. Hummers ◽  
Fredrick M. Wigley ◽  
Cynthia Anderson ◽  
Francesco Boin ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Intravenous Immunoglobulin ◽  
Randomized Clinical Trials ◽  
Type I Collagen ◽  
T Test ◽  
Type I ◽  
Single Center Experience ◽  
Paired Student ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
The Mean

Objective.We sought to retrospectively review a single-center experience using intravenous immunoglobulin (IVIG) for the treatment of refractory, active diffuse cutaneous systemic sclerosis (dcSSc).Methods.The mean modified Rodnan Skin score (mRSS) at baseline was compared to the mRSS at 6, 12, 18, and 24 months post-IVIG initiation by the paired Student t test. Changes in mRSS at 6 and 12 months were also compared to data from historical controls of 3 large, negative, multicenter, randomized clinical trials of other medications [D-penicillamine (D-pen), recombinant human relaxin (relaxin), and oral bovine type I collagen (collagen)] and to patients treated with mycophenolate mofetil (MMF) alone using the Student t test.Results.Thirty patients were treated with adjunctive IVIG (2 g/kg/mo) for refractory, active dcSSc. The mean baseline mRSS of our cohort was 29.6 ± 7.2, and this significantly decreased to 24.1 ± 9.6 (n = 29, p = 0.0011) at 6 months, 22.5 ± 10.0 (n = 25, p = 0.0001) at 12 months, 20.6 ± 11.8 (n = 23, p = 0.0001) at 18 months, and 15.3 ± 6.4 (n = 15, p < 0.0001) at 24 months. The mean change in mRSS at 6 months was not significantly different in the IVIG group (−5.3 ± 7.9) compared to the relaxin trial (−4.8 ± 6.99, p = 0.74) or MMF group (−3.4 ± 7.4, p = 0.26); however, at 12 months, the mean change in mRSS was significantly better in the IVIG group (−8 ± 8.3) than in the D-pen (−2.47 ± 8.6, p = 0.005) and collagen (−3.4 ± 7.12, p = 0.005) groups, and was comparable to the group of primary MMF responders (−7.1 ± 9, p = 0.67).Conclusion.Our observational study suggests that IVIG may be an effective adjunctive therapy for active dcSSc in patients failing other therapies.

scholarly journals Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): randomised, double-blind, placebo-controlled multicentre trial

2020 ◽  
Vol 79 (5) ◽  
pp. 618-625 ◽  
Author(s):  
Dinesh Khanna ◽  
Yannick Allanore ◽  
Christopher P Denton ◽  
Masataka Kuwana ◽  
Marco Matucci-Cerinic ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Vital Capacity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Potential Efficacy ◽  
Condition Score ◽  
Modified Rodnan Skin Score ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Pulmonary Arterial ◽  
Safety Assessments

ObjectivesRiociguat is approved for pulmonary arterial hypertension and has antiproliferative, anti-inflammatory and antifibrotic effects in animal models of tissue fibrosis. We evaluated the efficacy and safety of riociguat in patients with early diffuse cutaneous systemic sclerosis (dcSSc) at high risk of skin fibrosis progression.MethodsIn this randomised, double-blind, placebo-controlled, phase IIb trial, adults with dcSSc of <18 months' duration and a modified Rodnan skin score (mRSS) 10–22 units received riociguat 0.5 mg to 2.5 mg orally three times daily (n=60) or placebo (n=61). The primary endpoint was change in mRSS from baseline to week 52.ResultsAt week 52, change from baseline in mRSS units was –2.09±5.66 (n=57) with riociguat and –0.77±8.24 (n=52) with placebo (difference of least squares means –2.34 (95% CI –4.99 to 0.30; p=0.08)). In patients with interstitial lung disease, forced vital capacity declined by 2.7% with riociguat and 7.6% with placebo. At week 14, average Raynaud’s condition score had improved ≥50% in 19 (41.3%)/46 patients with riociguat and 13 (26.0%)/50 patients with placebo. Safety assessments showed no new signals with riociguat and no treatment-related deaths.ConclusionsRiociguat did not significantly benefit mRSS versus placebo at the predefined p<0.05. Secondary and exploratory analyses showed potential efficacy signals that should be tested in further trials. Riociguat was well tolerated.

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