Clinical trial NCT00146640: Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Official title: A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: active disease
morning stiffness of joints
nighttime application of prednisone
modified release prednisone
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.


Eligibility criteria: Inclusion Criteria:

* Active disease (inflammatory signs, erythrocyte sedimentation rate \[ESR\], C-reactive protein \[CRP\])
* 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:

* All contra-indications for glucocorticoids
* Pregnancy
* Concomitant treatment with biologics
* Intra-articular injections or synovectomy within the previous 4 months

Primary outcomes:
measure: Relative Change From Baseline in Duration of Morning Stiffness at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Recurrence of Joint Stiffness at Week 12
timeFrame: Week 12
measure: Relative Change From Baseline in Pain Intensity at Week 12
timeFrame: Baseline, Week 12
measure: Relative Change From Baseline in Quality of Sleep at Week 12
timeFrame: Baseline, Week 12
measure: Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline, Week 12
measure: Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12
timeFrame: Baseline, Week 12
measure: Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Research Site
city: Bad Kreuznach
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Frankfurt/Main
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.