Rheumatoid Arthritis (RA)Phase 4NCT01835613
Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.
A Phase 4 study testing Biomarkers Measures in people with Rheumatoid Arthritis (RA), run by Osservatorio Epidemiologico GISEA at 1 site in Italy.
Trial summary
The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Biomarkers Measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Patients aged 18 - 75 years;
- RA classified in compliance with the 2010 ACR/EULAR criteria;
- Patients that have to suspend a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination DMARDs / biological treatment;
- Patients for which is indicated to start a treatment with an inhibitor of IL-6R for high values indicative of systemic inflammation (ESR>=28 mm/hour, PCR>5 mg/l , Fibrinogen >400 mg/dl and or Albumin <3.5 g/dl) and high disease activity (DAS>2.4), or contraindications to DMARDs use which make it necessary to take biological drug in monotherapy.
- Corticosteroids therapy stable (< = 7.5 mg)for at least four weeks;
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- Joint symptoms for at least three but no more than 24 months from the screening visit;
- DAS44 >2.4 and/or SDAI >11
- Willing and able to comply with study procedures and timing.
Who cannot join
- On going pregnancy or lactation;
- Severe active infections;
- Patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol.
- Blood AST or ALT levels >5 times the upper normal limit;
- ANC count <0.5 x 109/L
- Platelet count <50 x103 /μL
- Patients with other autoimmune rheumatic diseases, in addition to AR (for example systemic lupus erythematosus [SLE], scleroderma, polymyositis, ecc…)
- Medical history or concomitant joint diseases in additions to AR (for example tophaceous gout, reactive arthritis, psoriatic arthritis).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Biomarkers Measures
- Keywords
- Rheumatoid Arthritis, Early RA, RA, IL-6, IL-6R, Inhibitor, Inhibition, Tocilizumab, Biomarkers, DMARDs, Biological, DAS, SDAI, AR/BIOM, OEG
- Medical subject headings
- Arthritis, Rheumatoid, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers MeasuresOther
At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Other | Biomarkers Measures
At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers. Receives: Other: Biomarkers Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score (DAS-44)
Measured: 12 months
Secondary outcomes (2)
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Measured: SDAI at 3-6-12-18 months
Biomarkers Measures
Evaluation by ELISA of the levels of the following biomarkers:
IL-8, MCP-1, Chemerin, IL-1α, IL-1β, IL-17, IL-23, TGFβ1, IL-10, BAFF.in the plasma:
Measured: Biomarkers Measures at 3-6-12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osservatorio Epidemiologico GISEA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianfranco Ferraccioli, Prof., Principal investigator, Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835613
- Sponsor's protocol ID
- AR/BIOM
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.
- ClinicalTrials.gov ID
- NCT01835613
- Acronym / sponsor ID
- AR/BIOM
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Early RA, RA, IL-6, IL-6R, Inhibitor, Inhibition, Tocilizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Osservatorio Epidemiologico GISEAUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Apr 2013 (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 purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Other | Other: Biomarkers MeasuresBiomarkers Measures At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent form;
- Patients aged 18 - 75 years;
- RA classified in compliance with the 2010 ACR/EULAR criteria;
- Patients that have to suspend a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination DMARDs / biological treatment;
- Patients for which is indicated to start a treatment with an inhibitor of IL-6R for high values indicative of systemic inflammation (ESR>=28 mm/hour, PCR>5 mg/l , Fibrinogen >400 mg/dl and or Albumin <3.5 g/dl) and high disease activity (DAS>2.4), or contraindications to DMARDs use which make it necessary to take biological drug in monotherapy.
Key exclusion criteria (8 listed)
- On going pregnancy or lactation;
- Severe active infections;
- Patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol.
- Blood AST or ALT levels >5 times the upper normal limit;
- ANC count <0.5 x 109/L
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 |
|---|---|---|
| Biomarkers MeasuresAt the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers. | Other | Tocilizumab |
Primary outcome
Disease Activity Score (DAS-44)
Time frame: 12 months
2 secondary outcomes
Simplified Disease Activity Index (SDAI);Biomarkers Measures
Time frame: SDAI at 3-6-12-18 months
Biomarkers Measures
Time frame: Biomarkers Measures at 3-6-12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
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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.
Gianfranco Ferraccioli, Prof. principal investigator
Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biomarkers Measures in people with Rheumatoid Arthritis (RA), run by Osservatorio Epidemiologico GISEA at 1 site in Italy.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Lapadula, Prof. (+39 080 5478866, info@oegisea.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score (DAS-44) (time frame: 12 months). 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 19 Apr 2013.