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

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ClinicalTrials.gov Identifier: NCT00525213
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : August 21, 2009
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Rob 803 Drug: Placebo Phase 2

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A Drug: Rob 803
two capsules per day during 12 weeks
Active Comparator: B Drug: Rob 803
two capsules per day during 12 weeks
Active Comparator: C Drug: Rob 803
two capsules per day during 12 weeks
Placebo Comparator: D Drug: Placebo
two capsules per day during 12 weeks

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525213

  Hide Study Locations
CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie
Bruxelles, Belgium
AZ Sint-Lucas Gent Reumatologie
Gent, Belgium
Reumainstituut Anne Frankplein 17
Hasselt, Belgium
Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski"
Pleven, Bulgaria, 5800
UMHAT sveti georgi
Ploviv, Bulgaria
Clinic of Rheumatology MHAT "Sveti Ivan Rilski"
Sofia, Bulgaria, 1431
Department of Rheumocardiology, Pulmonology and General Therapy
Sofia, Bulgaria, 1874
Clinic of Rheumatology, UMHAT "Sveta Marina",
Varna, Bulgaria, 9010
Academician V Tsitlanadze Scientific-Practical Centre of Rheumatolgoy
Tbilisi, Georgia
Rheumatology Department Cemotherapy and Immunotherapy Clinical
Tbilisi, Georgia
D Saulites-Kandevicas gimenes arsta prakse
Liepaja, Aldaru iela 8,, Latvia, LV 3401
Salenieces arsta reimatologa prakse
Valmiera, Latvia, LV4201
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, Lithuania
Centrum Miriada Prywatny Gabinet
Bialystok, Poland, Zelazna 9, lok.13U
Szpital Specjalistyczny Nr 1 Oddzial Reumatologii i Rehabilitacji
Bytom, Poland, 41-902
Poznanski Osrodek Medyczny Nova Med
Poznan, Poland
Indywidualna Specjalistyczna Praktyka
Szczecin, Poland
Centrum Medyczne Osteomed
Warszawa, Poland, 02-256
Prywatny Gabinet Lekarski
Wroclaw, Poland
"Sf. Maria" Clinical Hospital
Bucharest, Romania, 011172
"Dr. I. Cantacuzino" Clinical Hospital
Bucharest, Romania, 020475
Emergency Clinical County Hospital
Cluj Napoca, Romania, 400006
"Dr. Constantin Papilian"
Cluj-Napoca,, Romania
Rehabilitation Clinical Hospital
Lasi, Romania, 700662
Emergency County Hospital
Sibiu, Romania
Institute of Rheumatology Belgrade
Belgrade, Serbia
Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases
Niska Banja, Serbia
Reumatologiska kliniken Karolinska Sjukhuset
Stockholm, Sweden
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, United Kingdom
Sponsors and Collaborators
Principal Investigator: Lars Klareskog, Professor Karolinska University Hospital
More Information

Responsible Party: Ulf Björklund, OxyPharma AB
ClinicalTrials.gov Identifier: NCT00525213     History of Changes
Other Study ID Numbers: 2006-004834-33
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by OxyPharma:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors