Rheumatoid ArthritisNCT01476956
Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
An observational study of Rheumatoid Arthritis, run by CARE ARTHRITIS LTD. at 36 sites in 10 countries.
Trial summary
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. 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?
- Observational study
- How many people
- 571 participants
- Where
- 36 sitesin 10 countries
- Study dates
- Oct 2011to 31 Dec 2019
- Phase
- Observational
- 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
Study population: RA patients from rheumatologists' clinics
Who may be able to join
- 18 years of age or older
- RA according to the 2010 Rheumatoid Arthritis Classification Criteria
- Joint symptoms for ≥ 3 months prior to screening
- DAS44 > 2.4
- About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or
- increased dose of methotrexate by ≥10 mg weekly to a maximum dose of 25mg weekly (if already receiving >15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD),
Show all 12Show fewer
- add-on of alternative DMARD,
- switch to alternative DMARD,
- start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
- If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit
- If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit
- Patient will be available for follow up for a minimum of 24 months from the baseline visit
Who cannot join
- Intra-articular steroid injection within 4 weeks prior to the baseline visit
- Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)
- Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)
- History of:
- Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 3 months prior to the baseline visit;
- Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative)
- For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
Trial locations and contacts
36 sites in 10 countries.
36 sites in 10 countries
Canada7 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Division of Rheumatology, University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
The Arthritis Research Group
Newmarket, Ontario, L3Y 3R7
Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, S7K 0H6
University of Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Memorial University
St. John's, Newfoundland and Labrador, A1C 5B3
Arthritis Center, University of Manitoba
Winnipeg, Manitoba, R3A 1M4
France6 sites
Service de Rheumatologie-CHU Bordeaux Pellegrin
Bordeaux, 33000
Le Roux Liana, Centre d'Investigation Clinique
Brest, 29200
Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie
Lille
Departement de rheumatologie, Hopital Lapeyronie
Montpellier, 34295
Rheumatologie B, Hopital Cochin
Paris, 75014
Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan
Toulouse, 31059
Italy6 sites
University of Ferrara
Ferrara, 44121
University of Milan
Milan, 20157
Day Hospital Reumatologia
Milan, 20122
University of Padova
Padova, 35128
Catholic University of the Sacred Heart
Rome, 00168
Department of Rheumatology, University of Verona
Verona, 37067
United States5 sites
Johns Hopkins Arthritis Center, Johns Hopkins University
Baltimore, Maryland, 21224
Rheumatologist Hospital for Special Surgery
New York, New York, 10021
Division of Rheumatology, Columbia University, College of Physicians and Surgeons
New York, New York, 10032
Division of Allergy, Immunology and Rheumatology, University of Rochester
Rochester, New York, 14642
Seattle Rheumatology Associates
Seattle, Washington, 98104
Germany4 sites
Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology
Bad Nauheim, D-61231
Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie
Berlin
Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie
Jena, 07747
Dr Spieler
Zerbst, 39261
Netherlands4 sites
Amsterdam VU University Medical Centre
Amsterdam, 0157 AB Amsterdam
Academic Medical Centre/University of Amsterdam
Amsterdam, 1100 DE Amsterdam
Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen
Heerlen, 6419 PC Heerlen
Afdeling Reumatologie, Leids Universitair Medisch Centrum
Leiden, 2300 RC Leiden
Denmark1 site
Department of Rheumatology, Copenhagen University Hospital at Glostrup
Glostrup Municipality, DK-2600
Ireland1 site
Department of Rheumatology, St. Vincents University Hospital
Dublin
About this study
Official title: Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.
Disease activity will be monitored systematically every 3 months by the Disease Activity Score.
Read more
Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.
Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.
Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).
Patients will be followed for 2 years.
Read the detailed description
Treatment is Disease Activity Score (DAS) driven. Changes in standard DMARD and/or anti-TNFα therapy will be implemented according to 2010 European League against Rheumatism (EULAR) recommendations which state a target of remission (DAS44 <1.6) for patients receiving standard DMARD therapy in the setting of early disease and a target of low disease activity state (LDAS) (DAS44 ≤2.4) for patients receiving anti-TNFα therapy in the setting of established disease.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Observational study
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
RA patients on standard DMARD therapy
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).
Measured: 24 Months
Secondary outcomes (1)
To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completion31 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARE ARTHRITIS LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Walter P. Maksymowych, MD, Study director, CaRE Arthritis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476956
- Sponsor's protocol ID
- RA BIODAM
- Status last verified
- Oct 2021
- First submitted
- 1 Jun 2011
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sepriano A, Ramiro S, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewe R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.
PubMed 31523049Maksymowych WP, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewe R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.
PubMed 31474600
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01476956
- Acronym / sponsor ID
- RA BIODAM
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- CARE ARTHRITIS LTD.Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Oct 2011 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Nov 2011 (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.
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.
Disease activity will be monitored systematically every 3 months by the Disease Activity Score.
Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.
Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.
Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).
Patients will be followed for 2 years.
Detailed description
Treatment is Disease Activity Score (DAS) driven. Changes in standard DMARD and/or anti-TNFα therapy will be implemented according to 2010 European League against Rheumatism (EULAR) recommendations which state a target of remission (DAS44 <1.6) for patients receiving standard DMARD therapy in the setting of early disease and a target of low disease activity state (LDAS) (DAS44 ≤2.4) for patients receiving anti-TNFα therapy in the setting of established disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: Observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients from rheumatologists' clinics
Key inclusion criteria (12 listed)
- 18 years of age or older
- RA according to the 2010 Rheumatoid Arthritis Classification Criteria
- Joint symptoms for ≥ 3 months prior to screening
- DAS44 > 2.4
- About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or
Key exclusion criteria (8 listed)
- Intra-articular steroid injection within 4 weeks prior to the baseline visit
- Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)
- Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)
- History of:
- For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations
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 |
|---|---|---|
| Observational studyRA patients on standard DMARD therapy | Other | Rheumatoid Arthritis |
Primary outcome
To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).
Time frame: 24 Months
1 secondary outcome
To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy.
Time frame: 24 Months
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 27 Oct 2021.
- Derived from this study: PubMed 31523049Sepriano A, Ramiro S, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewe R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.
- Derived from this study: PubMed 31474600Maksymowych WP, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewe R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.
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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.
Walter P. Maksymowych, MD study director
CaRE Arthritis
36 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by CARE ARTHRITIS LTD. at 36 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 12 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: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Canada, France, Italy, United States, Germany 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA). (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476956, which also lists 2 linked publications.
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 27 Oct 2021.