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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.
Last refreshed on: 19 October 2017
Main ID:  NCT02072200
Date of registration: 14/02/2014
Prospective Registration: No
Primary sponsor: Mundipharma Korea Ltd
Public title: Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)
Scientific 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
Date of first enrolment: September 2013
Target sample size: 147
Recruitment status: Completed
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
Korea, Republic of
Name:     Seungjae Hong, PhD
Affiliation:  Kyunghee University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- 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

Exclusion Criteria:

- 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)

- 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.

Age minimum: 20 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Lodotra®
Primary Outcome(s)
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary [Time Frame: Baseline and 12 weeks]
Secondary Outcome(s)
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]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 08/08/2016
Date Completed:
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