World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT00146640
Date of registration: 06/09/2005
Prospective Registration: No
Primary sponsor: Merck KGaA, Darmstadt, Germany
Public title: Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Scientific 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
Date of first enrolment: August 31, 2004
Target sample size: 288
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00146640
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Germany Poland
Contacts
Name:     Medical Responsible
Address: 
Telephone:
Email:
Affiliation:  Merck KGaA, Darmstadt, Germany
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: IR Prednisone
Drug: MR Prednisone
Drug: Placebo - IR Prednisone
Drug: Placebo - MR Prednisone
Primary Outcome(s)
Relative Change From Baseline in Duration of Morning Stiffness at Week 12 [Time Frame: Baseline, Week 12]
Secondary Outcome(s)
Percentage of Participants With Recurrence of Joint Stiffness at Week 12 [Time Frame: Week 12]
Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 [Time Frame: Baseline, Week 12]
Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 [Time Frame: Baseline, Week 12]
Relative Change From Baseline in Pain Intensity at Week 12 [Time Frame: Baseline, Week 12]
Relative Change From Baseline in Quality of Sleep at Week 12 [Time Frame: Baseline, Week 12]
Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 [Time Frame: Baseline, Week 12]
Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 [Time Frame: Baseline, Week 12]
Secondary ID(s)
EMR 62215-003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 29/05/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00146640
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history