Rheumatoid ArthritisPhase 3TOVERANCT02837146
Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis
A Phase 3 study testing Tocilizumab (TCZ) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Maria Stoenoiu at 1 site in Belgium.
Trial summary
This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate (MTX). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab (TCZ) and Methotrexate (MTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to Dec 2019
- Phase
- Phase 3
- 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
- Diagnosis of RA fulfilling the 2010 EULAR/ACR (European League Against Rheumatism/ American College of Rheumatology classification criteria)
- Disease duration no longer than 12 months from the time of first swollen joint and no longer than 12 months from the time of initial diagnosis
- Age : 18-75 years
- Disease activity defined by a disease activity score DAS28-CRP > 3.2 or all must be met: tender joint count (TJC) of ≥4 and swollen joint count (SJC) ≥4
- US SH or PD synovitis scores >1 for at least 2 joints (MCP:2-5 or PIP:2-5 or CMC:2-5 or wrist joints or MTP:2-5 or ankle joints) and US SH or PD synovitis scores ≥1 for at least 1 other joint (MCP:2-5 or PIP:2-5 or or CMC:2-5 or wrist joints)
- Naïve to DMARDs (methotrexate, leflunomide, sulphasalazine) and naïve to any biologics or biosimilars.
Who cannot join
- History of other concomitant autoimmune disease such as lupus or psoriatic arthritis
- Meeting diagnostic criteria for any other rheumatic disease than RA (e.g. gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic arthritis, arthropathy or inflammatory bowel disease)
- Any previous treatment with :
- Biologics: Etanercept, infliximab, certolizumab, golimumab, abatacept, adalimumab, anakinra, tocilizumab, tofacitinib, etc.
- Any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti- CD3, anti-CD19 and anti-CD20
- Intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
Show all 38Show fewer
- Alkylating agents such as chlorambucil, or with total lymphoid irradiation
- Previous MCP arthroplasty or wrist arthrodesis. Participants who have undergone or are scheduled to undergo joint arthroplasties other than the MCP joints can be recruited in the study provided all other eligibility criteria are met.
- Current liver disease requiring medication
- Current symptoms of severe progressive or uncontrolled renal, hematologic, gastro-intestinal, pulmonary, cardiac, neurologic or cerebral disease whether or not related to rheumatoid arthritis, that would jeopardize inclusion in the protocol as judged by the clinician
- History of malignancy or lymphoproliferative disease, within the last 5 years, with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of cervix which that has been fully excised/cured with no evidence of recurrence
- Concomitant diagnosis or history of diverticulitis, peptic ulcer disease, diverticulosis requiring antibiotic treatment or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
- Evidence of active or latent bacterial, viral, fungal (except for fungal infections of nail beds), mycobacterial or other opportunistic infections at the time of potential enrolment
- Any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks or oral antibiotics within 2 weeks of screening'
- Herpes zoster or cytomegalovirus infection that resolved less than 2 months before the informed consent was signed
- Subjects at risk of tuberculosis (TB) are excluded if any of the following is present:
- A history of active TB within the last 3 years, even if treated Latent TB that was not successfully treated ≥ 4 weeks Current clinical radiographic, or laboratory evidence of active TB
- Subjects who received live vaccines within 4 weeks of the anticipated first dose of study medication. Live and live attenuated vaccines should not be given concurrently
- Subjects must agree not to take live attenuated vaccines (including seasonal nasal flu vaccine, varicella vaccine for shingles or chickenpox, MMR or MMRV, oral polio vaccine and vaccines for yellow fever, measles, mumps or rubella) thirty (30) days before the Screening Visit, throughout the duration of the trial and for sixty (60) days following the subject's last dose of study drug
- Subjects with positive test results for hepatitis B surface antigen or hepatitis C, or HIV detected with polymerase chain reaction or immunoblot assay
- Subjects with primary or secondary immunodeficiency
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- Major surgery within 8 weeks
- Patients with lack of peripheral venous access
- Pregnancy or breast-feeding
- Females of childbearing potential can only participate if using reliable contraception
- Intra-articular steroid injection in the joints assessed by US less than four weeks before screening
- Anticipated non-compliance with the protocol
- Laboratory exclusion criteria
- Platelet count <100 x 109/l (100,000/mm3)
- Haemoglobin <85 g/l (8.5 g/dl; 5.3 mmol/l) (<8.0)
- White Blood Cells <3.0 x 109/l (3000/mm3) or >14,000/μl
- Absolute Neutrophil Count <2.0 x 109/l (2000/mm3)
- Absolute Lymphocyte Count <0.5 x 109/l (500/mm3)
- Positive Hepatitis BsAg, or Hepatitis C antibody
- Serum creatinine >1.4 mg/dl (124 μmol/l) in female patients and >1.6 mg/dl (141 μmol/l) in male patients. Patients with serum creatinine values exceeding limits may be eligible if their GFR is >30
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN)
- Total Bilirubin > ULN
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Maria S Stoenoiu
Brussels, Belgium, 1200
Maria S. Stoenoiu, MD, PhD, +3227649917, maria.stoenoiu@uclouvain.be
Marie M M'Zoughui, +3227645390, marie.mzoughui@uclouvain.be
About this study
Official title: Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)
This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate (MTX).
Read the detailed description
For most rheumatic autoimmune diseases, treatment has two components: induction of remission and maintenance (to prevent relapse). After screening (week -3 to 0), patients enter into a 3 week run-in period during which no glucocorticoid (GC) treatment is allowed. At week 0, if persistent synovitis is confirmed patients will enter the induction phase. During the induction phase all patients will receive TCZ and MTX from week 0 to week 24. After week 24, all patients will receive MTX.
Ultrasound (US) is increasingly used in rheumatic diseases, in particular in rheumatoid arthritis (RA). The great resolution of superficial musculoskeletal structures obtained by using high frequency transducers and the high sensitivity of colour Doppler (CD) and power Doppler (PD) techniques allow to detect synovial vascularisation, synovial hypertrophy (SH) and joint effusion (JE).
This is a pilot US trial that allow us to explore the hypothesis that an early US response may be predictive of later clinical response.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab (TCZ), Methotrexate (MTX)
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocilizumab (TCZ)Biological
Also called Ro-Actemra
Induction phase: TCZ subcutaneously (162 mg weekly) from baseline to week 24
Methotrexate (MTX)Drug
Also called Ledertrexate, Emthexate
Induction and maintenance phase: Methotrexate 15-20 mg/week from baseline to week 54
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab (TCZ) + Methotrexate (MTX) | Experimental | Induction phase:
From week 0 to week 24, all subjects will receive TCZ and MTX
Maintenance phase:
From week 24 to week 54, all subjects will receive MTX Receives: Biological: Tocilizumab (TCZ); Drug: Methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global ultrasound scoring system (GLOSS) at MCP (2-5 joints of both hands) and wrist joints
MCP=metacarpophalangeal; GLOSS scoring according to OMERACT: Grade 0 or normal=normal joint (no synovial hypertrophy (SH), no Doppler signal); Grade1 or minimal=minimal synovitis (minimal SH, with ≤ grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate SH, with ≤ grade 2 Doppler signal or minimal SH and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe SH with ≤ grade 3 Doppler signal or minimal or moderate SH and grade 3 Doppler signal). Joints are scored 0 to 3, and the sum of individual joints scores represents the total GLOSS for a subject.
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
The earliest time point at which improvement in GLOSS at MCP (2-5 joints of both hands) and wrists can be detected
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Secondary outcomes (22)
GLOSS measured at 8 and 12 weeks is predictive to later clinical response at 24 and at 48 weeks
Measured: weeks 12, 24, 48
Minimum set of joints to be monitored by US in order to adequately assess disease activity
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in GLOSS for the whole US joint set
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in power Doppler (PD) scores for the whole US joint set
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in gray-scale (GS) scores for the whole US joint set
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in joint effusion (JE) scores for the whole US joint set
Measured: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Total PD score measured at 8 and 12 weeks is predictive to later clinical response at 24 and at 48 weeks
Measured: weeks 8, 12 , 24, 48
No radiographic progression assessed by Sharp/vdHeijde score
Measured: baseline to week 54
No new radiographic joint erosion at hands, wrists, ankles, feet
Measured: baseline to week 54
No new radiographic joint chondrolysis at hands, wrists, ankles, feet
Measured: baseline to week 54
No new swollen joint assessed by clinical examination
Measured: baseline to week 54
No new swollen joint assessed by ultrasound examination
Measured: baseline to week 54
DAS28 during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
SDAI during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
CDAI during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Swollen joint count score during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Tender joint count score for disease activity during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Patient visual analog score for disease activity during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Physician visual analog score for disease activity during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Number of patients fulfilling ACR/EULAR (2011) remission criteria during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Health assessment questionnaire(HAQ) score during the induction and maintenance phase
Measured: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Number of participants with serious adverse events(SAEs), with treatment-related SAEs, with discontinuations due to SAEs, with adverse events (AEs) with treatment-related AEs, with discontinuations due to AEs, death as outcome.
Measured: Days 1 to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Stoenoiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Stoenoiu, Université Catholique de Louvain
- Investigators
- Maria S Stoenoiu, MD, PhD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837146
- Sponsor's protocol ID
- P1200_14
- Other IDs
- 2015-001246-28, 2015
- Acronym
- TOVERA
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)
- ClinicalTrials.gov ID
- NCT02837146
- Acronym / sponsor ID
- TOVERA / P1200_14
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Maria StoenoiuUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Jul 2016 (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.
This study is aimed at assessing the kinetics of the ultrasound (US) response in DMARD-naive very early rheumatoid arthritis (RA) patients treated with tocilizumab (TCZ) and methotrexate (MTX).
Detailed description
For most rheumatic autoimmune diseases, treatment has two components: induction of remission and maintenance (to prevent relapse). After screening (week -3 to 0), patients enter into a 3 week run-in period during which no glucocorticoid (GC) treatment is allowed. At week 0, if persistent synovitis is confirmed patients will enter the induction phase. During the induction phase all patients will receive TCZ and MTX from week 0 to week 24. After week 24, all patients will receive MTX.
Ultrasound (US) is increasingly used in rheumatic diseases, in particular in rheumatoid arthritis (RA). The great resolution of superficial musculoskeletal structures obtained by using high frequency transducers and the high sensitivity of colour Doppler (CD) and power Doppler (PD) techniques allow to detect synovial vascularisation, synovial hypertrophy (SH) and joint effusion (JE).
This is a pilot US trial that allow us to explore the hypothesis that an early US response may be predictive of later clinical 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 (TCZ) + Methotrexate (MTX) | Experimental | Biological: Tocilizumab (TCZ), Drug: Methotrexate (MTX)Induction phase: From week 0 to week 24, all subjects will receive TCZ and MTX Maintenance phase: From week 24 to week 54, all subjects will receive MTX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of RA fulfilling the 2010 EULAR/ACR (European League Against Rheumatism/ American College of Rheumatology classification criteria)
- Disease duration no longer than 12 months from the time of first swollen joint and no longer than 12 months from the time of initial diagnosis
- Age : 18-75 years
- Disease activity defined by a disease activity score DAS28-CRP > 3.2 or all must be met: tender joint count (TJC) of ≥4 and swollen joint count (SJC) ≥4
- US SH or PD synovitis scores >1 for at least 2 joints (MCP:2-5 or PIP:2-5 or CMC:2-5 or wrist joints or MTP:2-5 or ankle joints) and US SH or PD synovitis scores ≥1 for at least 1 other joint (MCP:2-5 or PIP:2-5 or or CMC:2-5 or wrist joints)
Key exclusion criteria (38 listed)
- History of other concomitant autoimmune disease such as lupus or psoriatic arthritis
- Meeting diagnostic criteria for any other rheumatic disease than RA (e.g. gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic arthritis, arthropathy or inflammatory bowel disease)
- Any previous treatment with :
- Previous MCP arthroplasty or wrist arthrodesis. Participants who have undergone or are scheduled to undergo joint arthroplasties other than the MCP joints can be recruited in the study provided all other eligibility criteria are met.
- Current liver disease requiring medication
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 |
|---|---|---|
| Tocilizumab (TCZ)Also: Ro-ActemraInduction phase: TCZ subcutaneously (162 mg weekly) from baseline to week 24 | Biological | Tocilizumab (TCZ) + Methotrexate (MTX) |
| Methotrexate (MTX)Also: Ledertrexate, EmthexateInduction and maintenance phase: Methotrexate 15-20 mg/week from baseline to week 54 | Drug | Tocilizumab (TCZ) + Methotrexate (MTX) |
Primary outcome
Change in global ultrasound scoring system (GLOSS) at MCP (2-5 joints of both hands) and wrist joints
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
MCP=metacarpophalangeal; GLOSS scoring according to OMERACT: Grade 0 or normal=normal joint (no synovial hypertrophy (SH), no Doppler signal); Grade1 or minimal=minimal synovitis (minimal SH, with ≤ grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate SH, with ≤ grade 2 Doppler signal or minimal SH and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe SH with ≤ grade 3 Doppler signal or minimal or moderate SH and grade 3 Doppler signal). Joints are scored 0 to 3, and the sum of individual joints scores represents the total GLOSS for a subject.
The earliest time point at which improvement in GLOSS at MCP (2-5 joints of both hands) and wrists can be detected
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
22 secondary outcomes
GLOSS measured at 8 and 12 weeks is predictive to later clinical response at 24 and at 48 weeks
Time frame: weeks 12, 24, 48
Minimum set of joints to be monitored by US in order to adequately assess disease activity
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in GLOSS for the whole US joint set
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in power Doppler (PD) scores for the whole US joint set
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in gray-scale (GS) scores for the whole US joint set
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Change in joint effusion (JE) scores for the whole US joint set
Time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54
Total PD score measured at 8 and 12 weeks is predictive to later clinical response at 24 and at 48 weeks
Time frame: weeks 8, 12 , 24, 48
No radiographic progression assessed by Sharp/vdHeijde score
Time frame: baseline to week 54
No new radiographic joint erosion at hands, wrists, ankles, feet
Time frame: baseline to week 54
No new radiographic joint chondrolysis at hands, wrists, ankles, feet
Time frame: baseline to week 54
No new swollen joint assessed by clinical examination
Time frame: baseline to week 54
No new swollen joint assessed by ultrasound examination
Time frame: baseline to week 54
DAS28 during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
SDAI during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
CDAI during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Swollen joint count score during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Tender joint count score for disease activity during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Patient visual analog score for disease activity during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Physician visual analog score for disease activity during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Number of patients fulfilling ACR/EULAR (2011) remission criteria during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Health assessment questionnaire(HAQ) score during the induction and maintenance phase
Time frame: baseline to week 2, 4, 8, 12, 16, 24, 48, 54
Number of participants with serious adverse events(SAEs), with treatment-related SAEs, with discontinuations due to SAEs, with adverse events (AEs) with treatment-related AEs, with discontinuations due to AEs, death as outcome.
Time frame: Days 1 to 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Maria S Stoenoiu, MD, PhD principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab (TCZ) and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Maria Stoenoiu at 1 site in Belgium.
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 6 inclusion and 38 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 29 Jul 2016. 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 Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Maria S Stoenoiu, MD, PhD (+32 2 7645391, maria.stoenoiu@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global ultrasound scoring system (GLOSS) at MCP (2-5 joints of both hands) and wrist joints (time frame: Baseline to weeks 2, 4, 8, 12, 16, 24, 32, 40, 54). The study lists 2 primary outcomes in all. 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 29 Jul 2016.