Rheumatoid ArthritisPhase 2ROBUSTNCT00525213
Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate
A Phase 2 study testing Rob 803 in people with Rheumatoid Arthritis, run by OxyPharma at 34 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rob 803
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 34 sitesin 10 countries
- Study dates
- Oct 2007to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
Poland6 sites
Centrum Miriada Prywatny Gabinet
Bialystok, Zelazna 9, lok.13U
Szpital Specjalistyczny Nr 1 Oddzial Reumatologii i Rehabilitacji
Bytom, 41-902
Poznanski Osrodek Medyczny Nova Med
Poznan
Indywidualna Specjalistyczna Praktyka
Szczecin
Centrum Medyczne Osteomed
Warsaw, 02-256
Prywatny Gabinet Lekarski
Wroclaw
Romania6 sites
"Sf. Maria" Clinical Hospital
Bucharest, 011172
"Dr. I. Cantacuzino" Clinical Hospital
Bucharest, 020475
Emergency Clinical County Hospital
Cluj-Napoca, 400006
"Dr. Constantin Papilian"
Cluj-Napoca
Rehabilitation Clinical Hospital
Lasi, 700662
Emergency County Hospital
Sibiu
Bulgaria5 sites
Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski"
Pleven, 5800
UMHAT sveti georgi
Ploviv
Clinic of Rheumatology MHAT "Sveti Ivan Rilski"
Sofia, 1431
Department of Rheumocardiology, Pulmonology and General Therapy
Sofia, 1874
Clinic of Rheumatology, UMHAT "Sveta Marina",
Varna, 9010
United Kingdom4 sites
Musculo Skeletal dept Chapel Allerton Hospital
Leeds
Vectasearch Clinic Ltd St Mary's Hospital
Newport
Rheumatology Unit North Tyneside District General Hospital
North Shields
Norfolk and Norwich University Hospital
Norwich
Belgium3 sites
CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie
Brussels
AZ Sint-Lucas Gent Reumatologie
Ghent
Reumainstituut Anne Frankplein 17
Hasselt
Lithuania3 sites
Rheumatology Clinic Hospital of Kaunas University of Medicine
Kaunas
Department of Therapy and diagnostics Siauliai district hospital
Šiauliai
Center of Reumathology Vilnius University hospital Santariskiu Clinics
Vilnius
Georgia2 sites
Academician V Tsitlanadze Scientific-Practical Centre of Rheumatolgoy
Tbilisi
Rheumatology Department Cemotherapy and Immunotherapy Clinical
Tbilisi
Latvia2 sites
D Saulites-Kandevicas gimenes arsta prakse
Liepāja, Aldaru Iela 8,, LV 3401
Salenieces arsta reimatologa prakse
Valmiera, LV4201
Serbia2 sites
Institute of Rheumatology Belgrade
Belgrade
Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases
Niška Banja
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rob 803, Placebo
- Keywords
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rob 803Drug
two capsules per day during 12 weeks
PlaceboDrug
two capsules per day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Rob 803 |
| B | Active comparator | Not described Receives: Drug: Rob 803 |
| C | Active comparator | Not described Receives: Drug: Rob 803 |
| D | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- OxyPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lars Klareskog, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525213
- Sponsor's protocol ID
- 2006-004834-33
- Acronym
- ROBUST
- Status last verified
- Aug 2009
- First submitted
- 4 Sep 2007
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00525213
- Acronym / sponsor ID
- ROBUST / 2006-004834-33
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- OxyPharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Rob 803 |
| B | Active comparator | Drug: Rob 803 |
| C | Active comparator | Drug: Rob 803 |
| D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rob 803two capsules per day during 12 weeks | Drug | A, B, C |
| Placebotwo capsules per day during 12 weeks | Drug | D |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Klareskog, Professor principal investigator
Karolinska University Hospital
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rob 803 in people with Rheumatoid Arthritis, run by OxyPharma at 34 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Poland, Romania, Bulgaria, United Kingdom, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.