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Methotrexate and prednisone.Study Shows Methotrexate and Prednisone Combination Therapy Achieves Remission for Most RA Patients
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Advanced search. Log in via Institution. You are here Home Archive Volume 76, Issue 8 Long-term outcome is better when a methotrexate-based treatment strategy is combined with 10 mg prednisone daily: follow-up after the second Computer-Assisted Management in Early Rheumatoid Arthritis trial.
Email alerts. Article Text. Article menu. Resource links provided by the National Library of Medicine MedlinePlus related topics: Sarcoidosis Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methotrexate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate U.
Active Comparator: prednisolone Drug: Prednisolone Oral prednisolone start 40 mg daily, to be tapered to 10 mg daily for 24 weeks. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI mean fluorescence intensity.
Differences in phenotype of T-cells MFI in peripheral blood of sarcoidosis patients before, during and after treatment. Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Differences in phenotype of T-cells MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate.
Differences in phenotype of dendritic cells MFI in peripheral blood of sarcoidosis patients before, during and after treatment. Differences in phenotype of dendritic cells MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate.
Differences in expression of monocyte specific cell surface markers on monocytes MFI in peripheral blood of sarcoidosis patients before, during and after treatment. Differences expression of monocyte specific cell surface markers on monocytes MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate. Biomarkers are measured in peripheral blood and include:.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Contra-indication for methotrexate or corticosteroids:. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Limitations: Follow-up was short, and a high dose of folinic acid and a relatively high starting dosage of prednisone were used. Conclusions: Prednisone plus methotrexate is associated with shorter prednisone treatment and steroid sparing. It may be useful in patients at high risk for steroid-related toxicity. If patients did not go into remission after four months, they were randomized either to a combination of multiple DMARDS and low-dose prednisone arm 1 or to adalimumab ADA and methotrexate arm 2.
After 8 months, patients in arm 1 and 2 of the study achieved similar levels of remission. Video Series. Medications were withdrawn from patients if there was a significant decrease in their leukocyte or platelet count or a significant increase in their serum creatinine or transaminase levels. At the end of the study, 32 patients 89 percent in the methotrexate group and 30 83 percent in the placebo group were available for evaluation. More patients in the methotrexate group were free of steroids after 76 weeks than in the placebo group, even when the worst-case scenario was assumed for those who dropped out.
The efficacy of methotrexate was clear after 48 weeks, and the methotrexate patients also had significantly fewer flare-ups. Adverse reactions were not significantly different between the two trial groups. The authors conclude that using prednisone and methotrexate together to treat polymyalgia rheumatica can decrease the number of flare-ups and reduce the total dosage of prednisone required to achieve and maintain remission.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. Sarcoidosis is a multisystem, granulomatous disorder, most commonly affecting the lungs.
Symptom burden is high, and quality of life QoL and social participation are negatively affected. Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion. Prednisone is currently the first-choice therapy in pulmonary sarcoidosis and leads to short-term improvement of lung function.
Unfortunately, prednisone has major side-effects and is associated with impaired QoL. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects.
The investigators hypothesize that first-line treatment with methotrexate is as effective as prednisone, with fewer side-effects and better QoL. Layout table for study information Study Type : Interventional Clinical Trial Estimated Enrollment : participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, randomized, open-label, multi-center 18 hospitals in the Netherlandssingle country, non-inferiority trial.
Randomization to oral prednisone start 40 mg daily, to be tapered to 10 mg daily or oral methotrexate 15 mg weekly to be increased to 25 mg weekly for 24 weeks. Thereafter continuation of trial for 18 months on regular treatment investigator decision. Resource links provided by the National Library of Medicine MedlinePlus related topics: Sarcoidosis Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methotrexate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate U.
Active Comparator: prednisolone Drug: Prednisolone Oral prednisolone start 40 mg daily, to be tapered to 10 mg daily for 24 weeks. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI mean fluorescence intensity. Differences in phenotype of T-cells MFI in peripheral blood of sarcoidosis patients before, during and after treatment. Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment.
Differences in phenotype of T-cells MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate.
Differences in phenotype of dendritic cells MFI in peripheral blood of sarcoidosis patients before, during and after treatment.
Differences in phenotype of dendritic cells MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate. Differences in expression of monocyte specific cell surface markers on monocytes MFI in peripheral blood of sarcoidosis patients before, during and after treatment. Differences expression of monocyte specific cell surface markers on monocytes MFI in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate.
Biomarkers are measured in peripheral blood and include:. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Contra-indication for methotrexate or corticosteroids:.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : August 24, See Contacts and Locations. View this study on Beta. Study Description. This is a prospective, randomized, non-blinded, multi-center, non-inferiority trial designed to compare effectiveness and side-effects of methotrexate versus prednisolone as first-line therapy for pulmonary sarcoidosis.
Detailed Description:. Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methotrexate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate. FDA Resources. Arms and Interventions. Oral prednisolone start 40 mg daily, to be tapered to 10 mg daily for 24 weeks.
Outcome Measures. Change in hospital-measured FVC between baseline and 16 weeks. Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients before, during and after treatment. Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate. Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients before, during and after treatment.
Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate. Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients before, during and after treatment. Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes.
All scores range from 0 tohigher scores signifying beter health status. It takes about minutes to complete. Scores range from 0 - and higher scores signifying beter health quality. The minimal clinically important difference MCID is 0,5 points per item. Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation.
From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 towith a higher score representing a better QoL.
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from The fatigue assessment scale FAS is a item self-administered questionnaire about fatigue in patients with sarcoidosis.
Every week patients register whether they missed pills and the amount of pills wasted. Discontinuation or switch of medication is registered both by patients and researchers. Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an item questionnaire and patient experiences and side-effects with medication after 12 weeks in a item questionnaire on a Likert scale.
For each question it is different whether a higher score represents better or worse outcomes. Eligibility Criteria. A pulmonary indication for treatment and parenchymal involvement on X-ray or CT-scan conducted within three months before inclusion determined by the treating physician and conform current guidelines. For pulmonary functions tests GLI reference values are used.
Exclusion Criteria: Any condition or circumstance that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures.
Previous immunosuppressive treatment for sarcoidosis Use of systemic immunosuppressive therapy within the preceding three months for another disease than sarcoidosis Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study treatment or within 90 days after the last dose in the randomized study phase.
For males; planning to pro-create during the study or within 90 days after the last dose of the randomized study phase. Primary systemic treatment indication being an extra pulmonary location of sarcoidosis e.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. Antonius ziekenhuis. More Information. Publications automatically indexed to this study by ClinicalTrials. Design of a randomized controlled trial to evaluate effectiveness of methotrexate versus prednisone as first-line treatment for pulmonary sarcoidosis: the PREDMETH study. BMC Pulm Med. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Sarcoidosis, Pulmonary. Drug: Methotrexate Drug: Prednisolone.
Phase 4. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Prospective, randomized, open-label, multi-center 18 hospitals in the Netherlandssingle country, non-inferiority trial. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Drug: Methotrexate Oral methotrexate 15 mg weekly to be increased to 25 mg weekly for 24 weeks.
NEW YORK (Reuters Health)—Adding prednisone to methotrexate for early rheumatoid arthritis (RA) results in a lower initiation rate of a. Prednisone plus methotrexate is associated with shorter prednisone treatment and steroid sparing. It may be useful in patients at high risk for. The authors conclude that using prednisone and methotrexate together to treat polymyalgia rheumatica can decrease the number of flare-ups and. Using methotrexate together with predniSONE can increase the blood levels or add to the side effects of methotrexate Talk with your doctor before using. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. The investigators hypothesize that first-line. It takes about minutes to complete. Contact: B. Also, the absence of increased steroid morbidity in the higher-dose prednisone plus placebo group makes the clinical significance of this minimal prednisone dose reduction unclear. Long-term outcome is better when a methotrexate-based treatment strategy is combined with 10 mg prednisone daily: follow-up after the second Computer-Assisted Management in Early Rheumatoid Arthritis trial. Moonen, MD. Previous immunosuppressive treatment for sarcoidosis Use of systemic immunosuppressive therapy within the preceding three months for another disease than sarcoidosis Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study treatment or within 90 days after the last dose in the randomized study phase.After the trial, prednisone was tapered and stopped, if possible. The objective was to compare, during the post-trial follow-up between the two former strategy groups, initiation of the first biological disease-modifying antirheumatic drug bDMARD , radiographic outcome and onset of glucocorticoid GC -related comorbidities.
Results Of patients post-trial follow-up data were available. The maximum follow-up time was No significant differences between the former strategy groups in the onset of GC-related comorbidities during the post-trial follow-up were found. Conclusion Addition of 10 mg prednisone daily to an MTX-based treatment strategy in early rheumatoid arthritis results in a lower initiation rate of a first bDMARD and significantly better radiographic outcomes, yet does not result in more GC-related comorbidities.
You will be able to get a quick price and instant permission to reuse the content in many different ways. Contributors All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; drafted the work or revised it critically for important intellectual content and made a final approval of the version to be published.
MS was supported by a research grant from Astra Zeneca. Astra Zeneca was not involved in this study. Provenance and peer review Not commissioned; externally peer reviewed. Correction notice This article has been corrected since it published Online First. Skip to main content. Log in via OpenAthens. Log in using your username and password For personal accounts OR managers of institutional accounts.
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Email alerts. Article Text. Article menu. Clinical and epidemiological research. Concise report. Long-term outcome is better when a methotrexate-based treatment strategy is combined with 10 mg prednisone daily: follow-up after the second Computer-Assisted Management in Early Rheumatoid Arthritis trial.
Statistics from Altmetric. Footnotes Contributors All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; drafted the work or revised it critically for important intellectual content and made a final approval of the version to be published. Read the full text or download the PDF:. Log in.
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