Phase 3
Completed 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
Source: ClinicalTrials.gov NCT00146640 ↗Enrolled (actual)
288
Serious AEs
2.4%
Results posted
May 2018
Primary outcomePrimary: Relative Change From Baseline in Duration of Morning Stiffness at Week 12 — -22.7; -0.4 percent change
◆ Published Evidence
Highly cited
396citations · ~22 / year
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.
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.
Linked Publications (2)
-
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.
-
Hypothalamus-pituitary-adrenal axis function in patients with rheumatoid arthritis treated with nighttime-release prednisone.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.