Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)

NCT02072200 | Completed Phase 4 Results

• 1 other identifier: LOD13-KR-401
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Rheumatoid Arthritis

Keywords

RA, MS, Safety, Efficacy, MR prednisone

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (2)

• Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale

  Baseline and 12 weeks

• Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12

  12 weeks

Study Arms (1)

Modified release prednisone

EXPERIMENTAL

Single arm / Lodotra

Drug: Lodotra®

Interventions

Lodotra® DRUG

Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response

Also known as: Modified Release Prednisone

Modified release prednisone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Pyeongchon, Kyungkido, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Kim Bu Yeon
• Organization: Mundipharma Korea Ltd

BuYeon.Kim@mundipharma.co.kr

+82 2 568 5689

Study Officials

• Seungjae Hong, PhD

  Kyunghee University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 26, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 8, 2016
• Results First Posted: August 8, 2016

Record last verified: 2016-08

Locations

KR (1)