EUCTR2015-001246-28-BE
Active, not recruiting
Phase 1
ltrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA
Cliniques Universitaires Saint-Luc, Université catholique de Louvain0 sites45 target enrollmentJuly 23, 2015
ConditionsRheumatoid ArthritisMedDRA version: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsRoActemra
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Cliniques Universitaires Saint-Luc, Université catholique de Louvain
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •1\.Diagnosis of RA fulfilling the 2010 EULAR/ACR (European League Against Rheumatism/ American College of Rheumatology classification criteria)
- •2\.Disease duration no longer than 12 months from the time of initial diagnosis
- •3\.Age : 18\-70 years
- •4\.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
- •5\.US SH or PD synovitis scores \>1 for at least 2 metacarpophalangeal (MCP) joints (2\-5\) and US SH or PD synovitis scores \=1
- •6\.Naïve to DMARD (methotrexate, leflunomide, sulphasalazine) and biologics (TNF\-, IL6\-, CD20\-, IL1\-blockers)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Exclusion criteria
- •1\.History of other concomitant autoimmune disease such as lupus or psoriatic arthritis
- •2\.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)
- •3\.Any previous treatment with :
- •a.Etanercept, infliximab, certolizumab, golimumab, abatacept or adalimumab, anakinra
- •b.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
- •c.Intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.
- •d.Alkylating agents such as chlorambucil, or with total lymphoid irradiation
- •4\.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.
- •5\.Current liver disease requiring medication
Outcomes
Primary Outcomes
Not specified
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