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Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis.


- candidate number8706
- NTR NumberNTR2630
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2010
- Secondary IDs10/173 METC AMC
- Public TitleEffects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis.
- Scientific TitleEffects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis.
- ACRONYM
- hypothesisThere might be biomarkers in infected synovial tissue which have predicting value on the effectiveness of Abatacept on RA.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. Men/women suffering from rheumatoid arthritis, based on the American Rheumatism Association (ARA) 1987 criteria, who failed methotrexate treatment, will be eligible for the study;
2. Patients in ARA functional classes I, II, and III may be included.

In addition, patients must fulfill the following criteria at baseline:
1. DAS 28-CRP > 3.2;
2. Be > 18 years of age and < 85 years;
3. Use concurrent methotrexate treatment (5 - 30 mg/week; stable for at least 28 days before study initiation) during the study. Subjects may be taking nonsteroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy < 10 mg/day provided that the dosage has been stable for at least 1 month prior to entry.
- Exclusion criteria1. Pregnancy;
2. Breastfeeding;
3. Subjects who are impaired, incapacitated, or incapable of completing study related assessments;
4. Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous);
5. Subjects who have previously received treatment with an investigational biologic RA therapy, anti-TNF therapy, rituximab, tocilizumab or abatacept;
6. Subjects with active vasculitis of a major organ system with the exception of rheumatoid nodules;
7. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study;
8. Subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing;
9. Subjects who have clinically significant drug or alcohol abuse;
10. Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis);
11. Subjects at risk for tuberculosis (TB). Specifically, subjects with:
A. A history of active TB within the last 3 years even if it was treated;
B. A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type;
C. Current clinical, radiographic or laboratory evidence of active TB;
D. Latent TB which was not successfully treated.
12. Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent;
13. Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection detected during screening;
14. Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication or who will have need of a live vaccine at any time following Day 1 of the study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2010
- planned closingdate1-nov-2011
- Target number of participants16
- InterventionsTo study changes in synovial inflammation in serial biopsy samples following the administration of abatacept in patients with active rheumatoid arthritis.
Synovial biopsies from an actively inflamed joint (knee, ankle or wrist) will be obtained by mini-arthroscopy or ultrasound guided biopsy before administration of abatacept and at week 16 of treatment.
- Primary outcomeTo study changes in synovial inflammation in serial biopsy samples following administration of abatacept therapy to subjects with active rheumatoid arthritis.
- Secondary outcome1. Assess clinical response;
2. Assess cellular responses of synovial explants to inflammatory stimuli, and/or antagonists, before and after treatment with abatacept;
3. Identify synovial biomarkers predictive of the clinical response to abatacept treatment;
4. Investigate the changes in phenotypes of peripheral blood mononuclear cells (PBMCs).
- TimepointsIn total there will be 9 study visits:
Screening, baseline, week 2, week 4, week 8, week 12, week 16, week 20 and week 24. There will be a ± 3 day deviation for all return visits. All visits will be fixed with reference to the baseline visit.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD25-nov-2010 - 11-dec-2010


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