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Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00146640
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MR Prednisone Drug: IR Prednisone Drug: Placebo - MR Prednisone Drug: Placebo - IR Prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2004
Actual Primary Completion Date : January 31, 2007
Actual Study Completion Date : January 31, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Drug: Placebo - IR Prednisone
Participants will receive placebo matching to IR prednisone tablet in the morning.

Active Comparator: 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.
Drug: IR Prednisone
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.

Drug: Placebo - MR Prednisone
Participants will receive placebo matching to MR prednisone tablet at bed time.




Primary Outcome Measures :
  1. Relative Change From Baseline in Duration of Morning Stiffness at Week 12 [ Time Frame: Baseline, Week 12 ]
    Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.


Secondary Outcome Measures :
  1. Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 [ Time Frame: Baseline, Week 12 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than oe equal to (≤) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 >5.1 = severe disease activity. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.

  2. Percentage of Participants With Recurrence of Joint Stiffness at Week 12 [ Time Frame: Week 12 ]
    Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported.

  3. Relative Change From Baseline in Pain Intensity at Week 12 [ Time Frame: Baseline, Week 12 ]
    Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.

  4. Relative Change From Baseline in Quality of Sleep at Week 12 [ Time Frame: Baseline, Week 12 ]
    Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.

  5. Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 [ Time Frame: Baseline, Week 12 ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.

  6. Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.

  7. Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = ([value at Week 12 minus value at Baseline] divided by [value at baseline]) multiplied by 100.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.gov identifier (NCT number): NCT00146640


Locations
Germany
Research Site
Aachen, Germany
Research Site
Bad Kreuznach, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Erlangen, Germany
Research Site
Frankfurt/Main, Germany
Research Site
Hamburg, Germany
Research Site
Hannover, Germany
Research Site
Jena, Germany
Research Site
Köln, Germany
Research Site
Leipzig, Germany
Research Site
München, Germany
Research Site
Ratingen, Germany
Research Site
Rostock, Germany
Poland
Research Site
Bialystok, Poland
Research Site
Katowice, Poland
Research Site
Kraków, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Sopot, Poland
Research Site
Torun, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA

Publications of Results:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00146640     History of Changes
Other Study ID Numbers: EMR 62215-003
First Posted: September 7, 2005    Key Record Dates
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018
Last Verified: September 2017

Keywords provided by Merck KGaA:
active disease
morning stiffness of joints
nighttime application of prednisone
modified releae prednisone

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents