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
NCT00146640, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis. Trials, record NCT00146640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00146640
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT00146640
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 288 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Rheumatoid Arthritis
- Interventions
- MR Prednisone, IR Prednisone, Placebo - MR Prednisone, Placebo - IR Prednisone
- First posted
- 2005-09-07
- Last updated
- 2018-07-03
- Results first posted
- 2018-05-29
- Limitations and caveats
- For SAEs, due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relative Change From Baseline in Duration of Morning Stiffness at Week 12 | 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 | Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 | 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 or 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. |
| Secondary | Percentage of Participants With Recurrence of Joint Stiffness at Week 12 | 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. |
| Secondary | Relative Change From Baseline in Pain Intensity at Week 12 | 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. |
| Secondary | Relative Change From Baseline in Quality of Sleep at Week 12 | 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. |
| Secondary | Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | 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. |
| Secondary | Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 | 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. |
| Secondary | Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relative Change From Baseline in Duration of Morning Stiffness at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Recurrence of Joint Stiffness at Week 12 | Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Relative Change From Baseline in Pain Intensity at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Relative Change From Baseline in Quality of Sleep at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
| SECONDARY | Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12 | Baseline, Week 12 | ITT Population. Here, overall number of participants analyzed = participants with available data for this outcome measure. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relative Change From Baseline in Duration of Morning Stiffness at Week 12 | MR Prednisone | -22.7 | Standard Deviation 89.1 | percent change | |
| Relative Change From Baseline in Duration of Morning Stiffness at Week 12 | IR Prednisone | -0.4 | Standard Deviation 89.0 | percent change | |
| Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 | MR Prednisone | -9.03 | 95% Confidence Interval -11.9 to -6.2 | percent change | |
| Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12 | IR Prednisone | -12.30 | 95% Confidence Interval -15.2 to -9.4 | percent change | |
| Percentage of Participants With Recurrence of Joint Stiffness at Week 12 | MR Prednisone | 47 | percentage of participants | ||
| Percentage of Participants With Recurrence of Joint Stiffness at Week 12 | IR Prednisone | 43 | percentage of participants | ||
| Relative Change From Baseline in Pain Intensity at Week 12 | MR Prednisone | -8.57 | 95% Confidence Interval -17.7 to 0.6 | percent change | |
| Relative Change From Baseline in Pain Intensity at Week 12 | IR Prednisone | -6.53 | 95% Confidence Interval -20.4 to 7.3 | percent change | |
| Relative Change From Baseline in Quality of Sleep at Week 12 | MR Prednisone | 4.63 | 95% Confidence Interval -9.9 to 19.1 | percent change | |
| Relative Change From Baseline in Quality of Sleep at Week 12 | IR Prednisone | 0.13 | 95% Confidence Interval -12.3 to 12.5 | percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MR Prednisone | 144 | |
| Overall Study | STARTED | IR Prednisone | 144 | |
| Overall Study | COMPLETED | MR Prednisone | 121 | |
| Overall Study | COMPLETED | IR Prednisone | 130 | |
| Overall Study | NOT COMPLETED | MR Prednisone | 23 | |
| Overall Study | NOT COMPLETED | IR Prednisone | 14 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MR Prednisone | 4 | 144 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | IR Prednisone | 8 | 144 | |
| other | Rheumatoid arthritis | Immune system disorders | MR Prednisone | 11 | 144 | |
| other | Rheumatoid arthritis | Immune system disorders | IR Prednisone | 13 | 144 | |
| other | Abdominal pain (upper) | Gastrointestinal disorders | MR Prednisone | 5 | 144 | |
| other | Abdominal pain (upper) | Gastrointestinal disorders | IR Prednisone | 8 | 144 | |
| serious | General disorders | MR Prednisone | 4 | 144 | ||
| serious | General disorders | IR Prednisone | 3 | 144 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MR Prednisone | ||
| Total, all-cause mortality | IR Prednisone | ||
| Total, other adverse events | MR Prednisone | 20 | 144 |
| Total, other adverse events | IR Prednisone | 29 | 144 |
| Total, serious adverse events | MR Prednisone | 4 | 144 |
| Total, serious adverse events | IR Prednisone | 3 | 144 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MR Prednisone vs IR Prednisone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00146640
GET https://conductscience.org/api/trials/v1/NCT00146640/registered