NCT02072200 is a Phase 4 clinical trial of Lodotra® in Rheumatoid Arthritis, sponsored by Mundipharma Korea Ltd.

Who is sponsoring NCT02072200?

NCT02072200 is sponsored by Mundipharma Korea Ltd.

What drugs are being tested in NCT02072200?

Interventions in NCT02072200: Lodotra®.

What condition does NCT02072200 study?

NCT02072200 studies Rheumatoid Arthritis.

Is NCT02072200 still recruiting?

NCT02072200 is currently completed. Last updated 5 August 2016.

Are results published for NCT02072200?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-08-05 · How we verify

NCT02072200

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness

Completed Phase 4 Results posted Last updated 5 August 2016

What this trial tests

Phase 4 trial testing Lodotra® in Rheumatoid Arthritis in 147 participants. Completed in 1 April 2015.

Timeline

1 September 2013

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	Mundipharma Korea Ltd
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	147
Start date	1 September 2013
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	1 location across South Korea

Drugs / interventions tested

Lodotra® — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Mundipharma Korea Ltd — full company profile →

Who can join

Adults 20 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Mundipharma Korea Ltd trials

Trials by the same sponsor.

NCT04124510 — Efficacy and Safety of Flutiform K-haler in Patients With Uncontrolled Asthma Following Mid-dose ICS/LABA DPI Therapy · Phase 3 · terminated
NCT03768466 — Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Trea · Phase 4 · completed
NCT02732886 — Betafoam Diabetes Mellitus Foot Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02072200 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mundipharma Korea Ltd
Last refreshed: 5 August 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02072200.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing