Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

Rheumatoid Arthritis Clinical Trial

— ROBUST  

Official title:

A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Stable Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525213
• Other study ID #: 2006-004834-33
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2007
• Last updated: August 20, 2009
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: OxyPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthRomania: National Medicines AgencySerbia and Montenegro: Agency for Drugs and Medicinal DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGeorgia:National Medicines AgencyPoland:National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

Description:

Rheumatoid arthritis (RA) is a common, chronic, disabling systemic autoimmune disease in which inflammation of the joint lining (synovium) occurs when the body's tissues are attacked by the immune system. The joint inflammation begins in the synovium and slowly destroys the cartilage, narrowing the joint and eventually damaging the bone. A large amount of inflammatory mediators or rheumatoid factors are synthesised in the joint which accelerate proliferation and differentiation of immune cells further to amplify the autoimmune reaction. A widely accepted model has emerged in which the presence of inflammation in established RA is driven by interactions between T cells, macrophages, and fibroblasts in an abnormal microenvironment.

Rheumatoid arthritis has an annual incidence of approximately 0.2 per 1000 in males and 0.4 per 1000 in females. In general, higher rates have been reported in the USA than in European populations. The incidence of RA increases with age until the mid 70s. A prevalence of 0.5-1% is reported in diverse populations world-wide.

Treatments for RA focus on relieving pain, reducing inflammation, slowing or stopping joint damage, and improving patients' well being and ability to function. Current therapies include non-steroidal anti-inflammatory drugs (NSAIDs) which target the clinical features of the disease to alleviate the pain and swelling that accompany RA, disease-modifying anti-rheumatic drugs (DMARDs) which target the actual cause of the disease and biological agents which are genetically engineered to target and modify the autoimmune response. Non-steroidal anti-inflammatory drugs are effective in managing the symptoms of RA, but are limiting as they cannot suppress progression of the disease. First line treatment on confirmation of RA is the use of DMARDs, supported by pain relief medication.

Biologic agents (TNF antagonists, anti B-cell agents and anti-interleukins) have proven effective in RA symptoms management. TNF antagonists have become an important therapeutic option in the treatment of advanced RA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with RA based on the ARA 1987 revised criteria at least 16 weeks prior to study enrolment, Day 0

• Have an ACR global functional status class of 1 to 3

• Have active disease, defined as the presence of 6 swollen joints and 6 tender joints in a 44 joint examination

• Have a CRP level at screening of = 1.5 mg/dL

• Have been taking oral or parenteral methotrexate (15 mg weekly or above), have been using methotrexate for at least 16 weeks (up to Day 0 of study), and have been on a stable dose for at least 8 weeks, up to Day 0.

Exclusion Criteria:

• Arthritis onset prior to 16 years old

• Any of the following infections:

• Known or acute infection that may affect CRP levels

• Active tuberculosis

• Known chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) including positive serology

• Ongoing systemic inflammatory condition which may interfere with the results of clinical or laboratory tests planned in the study (eg, systemic lupus erythematosus or any other systemic rheumatic disease other than RA)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rob 803
two capsules per day during 12 weeks
• Placebo
two capsules per day during 12 weeks

Locations

Country	Name	City	State
Belgium	CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie	Bruxelles
Belgium	AZ Sint-Lucas Gent Reumatologie	Gent
Belgium	Reumainstituut Anne Frankplein 17	Hasselt
Bulgaria	Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski"	Pleven
Bulgaria	UMHAT sveti georgi	Ploviv
Bulgaria	Clinic of Rheumatology MHAT "Sveti Ivan Rilski"	Sofia
Bulgaria	Department of Rheumocardiology, Pulmonology and General Therapy	Sofia
Bulgaria	Clinic of Rheumatology, UMHAT "Sveta Marina",	Varna
Georgia	Academician V Tsitlanadze Scientific-Practical Centre of Rheumatolgoy	Tbilisi
Georgia	Rheumatology Department Cemotherapy and Immunotherapy Clinical	Tbilisi
Latvia	D Saulites-Kandevicas gimenes arsta prakse	Liepaja	Aldaru iela 8,
Latvia	Salenieces arsta reimatologa prakse	Valmiera
Lithuania	Rheumatology Clinic Hospital of Kaunas University of Medicine	Kaunas
Lithuania	Department of Therapy and diagnostics Siauliai district hospital	Siauliai
Lithuania	Center of Reumathology Vilnius University hospital Santariskiu Clinics	Vilnius
Poland	Centrum Miriada Prywatny Gabinet	Bialystok
Poland	Szpital Specjalistyczny Nr 1 Oddzial Reumatologii i Rehabilitacji	Bytom
Poland	Poznanski Osrodek Medyczny Nova Med	Poznan
Poland	Indywidualna Specjalistyczna Praktyka	Szczecin
Poland	Centrum Medyczne Osteomed	Warszawa
Poland	Prywatny Gabinet Lekarski	Wroclaw
Romania	"Dr. I. Cantacuzino" Clinical Hospital	Bucharest
Romania	"Sf. Maria" Clinical Hospital	Bucharest
Romania	Emergency Clinical County Hospital	Cluj Napoca
Romania	"Dr. Constantin Papilian"	Cluj-Napoca,
Romania	Rehabilitation Clinical Hospital	Lasi
Romania	Emergency County Hospital	Sibiu
Serbia	Institute of Rheumatology Belgrade	Belgrade
Serbia	Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases	Niska Banja
Sweden	Reumatologiska kliniken Karolinska Sjukhuset	Stockholm
United Kingdom	Musculo Skeletal dept Chapel Allerton Hospital	Leeds
United Kingdom	Vectasearch Clinic Ltd St Mary's Hospital	Newport
United Kingdom	Rheumatology Unit North Tyneside District General Hospital	North Shields
United Kingdom	Norfolk and Norwich University Hospital	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
OxyPharma

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Georgia,  Latvia,  Lithuania,  Poland,  Romania,  Serbia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.		12 weeks	Yes
Secondary	Evaluate the safety of Rob 803 administered orally once daily in combination with a stable dose of methotrexate in subjects with moderate or severe active RA		12 weeks	Yes