Rheumatoid ArthritisPhase 4NCT02072200
Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)
A Phase 4 study testing Lodotra® in people with Rheumatoid Arthritis, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial summary
This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Lodotra®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed more than 3 months
- Morning stiffness on previous treatment with or without oral steroids (below or equal to 10mg per day, methylprednisolone doses were converted into prednisone doses as follows: prednisone dosed=methylprednisolone dose*1.25), average daily duration of 45 min or more.
- Average daily maximum pain intensity score (100 mm VAS) of 30mm or more.
- DAS-ESR ≥3.2
- On DMARD treatment including MTX for ≥3months and stable treatment dose within the past 30 days. There are no limitations on number of DMARDs treatment.(Except patients who have experience of adverse drug reaction of MTX or difficulty to administer MTX due to disease specific condition.)
- Able to perform study procedures and given written informed consent.
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- Naïve patients with Prednisone MR(Lodotra® ) or patients not treat with Prednisone MR(Lodotra®) within 4 weeks(28days)
- Subject who keeps to administer study drug at 22±30 daily
- Subject who provide signed and dated written voluntary informed consent
Who cannot join
- Patients who suffers from another disease, which requires glucocorticoid treatment during the study period.
- Synovectomy within 4 months prior to study start.
- Patients who underwent joint injections on only fingers and wrists(both sides) within 4 weeks prior to first visit. Clinically significant disease which, in the investigator's opinion, would exclude the subject from the study.
- Significant renal impairment (serum creatinine>2.0mg/dl)
- Significant hepatic impairment (>3 times the upper limit of normal range in each site)
- All contra-indications for glucocorticoids.(established new osteoporotic fractures history of corticoid psychosis, herpes simplex and herpes zoster, varicella infection)
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- Uncontrolled DM(HbA1c>8.0)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are:
- women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- women whose partners have been sterilized by vasectomy or other means
- two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Participation in another clinical study within the past 30 days
- Known hypersensitivity to prednisone
- Infection patients without effective antimicrobial and systemic mycosis infection patients(infection might be aggravated due to suppression of immunologic function.)
- Patients with immunization with live vaccines within 2 weeks of enrollment or planned during the study
- Since this drug contains glucose, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this drug.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Pyeongchon, Kyungkido
About this study
Official title: A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness
This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4).
Read the detailed description
Test Treatment, Dose, and Mode of Administration:
Starting dose is 10mg, and depending on the clinical symptoms and the patient's response, the initial dose can quickly be reduced to a lower maintenance dose. When changing over from the standard regimen (glucocorticoid administration in the morning) to Lodotra® administered at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained, if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed more than 10mg.
Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the evening meal, it is recommended to take Lodotra® with a light meal or snack.
Modified-release tablets are not to be broken, divided or chewed.
Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be obtained, and subjects will undergo complete evaluation for study eligibility) No dose increase will be allowed for more than 10mg
- Conditions
- Rheumatoid Arthritis
- Being tested
- Lodotra®
- Keywords
- RA, MS, Safety, Efficacy, MR prednisone
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lodotra®Drug
Also called Modified Release Prednisone
Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
| Study group | Role | What they receive |
|---|---|---|
| Modified release prednisone | Experimental | Single arm / Lodotra Receives: Drug: Lodotra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.
Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.
Measured: Baseline and 12 weeks
Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seungjae Hong, PhD, Principal investigator, Kyunghee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072200
- Sponsor's protocol ID
- LOD13-KR-401
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2014
- Last updated
- 8 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness
- ClinicalTrials.gov ID
- NCT02072200
- Acronym / sponsor ID
- LOD13-KR-401
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA, MS, Safety, Efficacy, MR prednisone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 8 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4).
Detailed description
Test Treatment, Dose, and Mode of Administration:
Starting dose is 10mg, and depending on the clinical symptoms and the patient's response, the initial dose can quickly be reduced to a lower maintenance dose. When changing over from the standard regimen (glucocorticoid administration in the morning) to Lodotra® administered at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained, if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed more than 10mg.
Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the evening meal, it is recommended to take Lodotra® with a light meal or snack.
Modified-release tablets are not to be broken, divided or chewed.
Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be obtained, and subjects will undergo complete evaluation for study eligibility) No dose increase will be allowed for more than 10mg
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified release prednisone | Experimental | Drug: Lodotra®Single arm / Lodotra |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are diagnosed more than 3 months
- Morning stiffness on previous treatment with or without oral steroids (below or equal to 10mg per day, methylprednisolone doses were converted into prednisone doses as follows: prednisone dosed=methylprednisolone dose*1.25), average daily duration of 45 min or more.
- Average daily maximum pain intensity score (100 mm VAS) of 30mm or more.
- DAS-ESR ≥3.2
- On DMARD treatment including MTX for ≥3months and stable treatment dose within the past 30 days. There are no limitations on number of DMARDs treatment.(Except patients who have experience of adverse drug reaction of MTX or difficulty to administer MTX due to disease specific condition.)
Key exclusion criteria (17 listed)
- Patients who suffers from another disease, which requires glucocorticoid treatment during the study period.
- Synovectomy within 4 months prior to study start.
- Patients who underwent joint injections on only fingers and wrists(both sides) within 4 weeks prior to first visit. Clinically significant disease which, in the investigator's opinion, would exclude the subject from the study.
- Significant renal impairment (serum creatinine>2.0mg/dl)
- Significant hepatic impairment (>3 times the upper limit of normal range in each site)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lodotra®Also: Modified Release PrednisoneSingle arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response | Drug | Modified release prednisone |
Primary outcome
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
Time frame: Baseline and 12 weeks
Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness. Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure.
2 secondary outcomes
Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
Time frame: Baseline and 12 weeks
Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seungjae Hong, PhD principal investigator
Kyunghee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lodotra® in people with Rheumatoid Arthritis, run by Mundipharma Korea Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.