Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
NCT ID: NCT00146640
Last Updated: 2018-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
288 participants
INTERVENTIONAL
2004-08-31
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MR Prednisone
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks.
MR Prednisone
Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time.
Placebo - IR Prednisone
Participants will receive placebo matching to IR prednisone tablet in the morning.
IR Prednisone
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks.
IR Prednisone
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Placebo - MR Prednisone
Participants will receive placebo matching to MR prednisone tablet at bed time.
Interventions
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MR Prednisone
Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time.
IR Prednisone
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Placebo - MR Prednisone
Participants will receive placebo matching to MR prednisone tablet at bed time.
Placebo - IR Prednisone
Participants will receive placebo matching to IR prednisone tablet in the morning.
Eligibility Criteria
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Inclusion Criteria
* Stable condition
* Stable basic treatments
* Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (\>/=) 45 minutes
Exclusion Criteria
* Pregnancy
* Concomitant treatment with biologics
* Intra-articular injections or synovectomy within the previous 4 months
18 Years
80 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Research Site
Aachen, , Germany
Research Site
Bad Kreuznach, , Germany
Research Site
Berlin, , Germany
Research Site
Cologne, , Germany
Research Site
Dresden, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Erlangen, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Hamburg, , Germany
Research Site
Hanover, , Germany
Research Site
Jena, , Germany
Research Site
Leipzig, , Germany
Research Site
München, , Germany
Research Site
Ratingen, , Germany
Research Site
Rostock, , Germany
Research Site
Bialystok, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Sopot, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Countries
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References
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Alten R, Doring G, Cutolo M, Gromnica-Ihle E, Witte S, Straub R, Buttgereit F. Hypothalamus-pituitary-adrenal axis function in patients with rheumatoid arthritis treated with nighttime-release prednisone. J Rheumatol. 2010 Oct;37(10):2025-31. doi: 10.3899/jrheum.100051. Epub 2010 Aug 3.
Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, Jeka S, Krueger K, Szechinski J, Alten R. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet. 2008 Jan 19;371(9608):205-14. doi: 10.1016/S0140-6736(08)60132-4.
Other Identifiers
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EMR 62215-003
Identifier Type: -
Identifier Source: org_study_id
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