Phase 3
N=288
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00146640 ↗Enrolled (actual)
288
Serious AEs
2.4%
Results posted
May 2018
Primary outcome: Primary: Relative Change From Baseline in Duration of Morning Stiffness at Week 12 — -22.7; -0.4 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MR Prednisone (Drug); IR Prednisone (Drug); Placebo - MR Prednisone (Drug); Placebo - IR Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline in Duration of Morning Stiffness at Week 12 |
-22.7; -0.4 | — |
| SECONDARY Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 |
-9.03; -12.30 | — |
| SECONDARY Percentage of Participants With Recurrence of Joint Stiffness at Week 12 |
47; 43 | — |
| SECONDARY Relative Change From Baseline in Pain Intensity at Week 12 |
-8.57; -6.53 | — |
| SECONDARY Relative Change From Baseline in Quality of Sleep at Week 12 |
4.63; 0.13 | — |
| SECONDARY Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 |
0.07; -4.7 | — |
| SECONDARY Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 |
10.63; 18.08 | — |
| SECONDARY Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 |
19.43; 21.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00146640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.