The primary objective is to determine if intra-articular etanercept therapy reduces the clinical signs and symptoms of inflammatory arthritis and improve outcome (beneficial effect). The secondary objective is to study safety and to analyse…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in clinical symptoms of
inflammatory arthritis between placebo and intervention group. Success of
treatment will be defined by the composite change index (CCI) at multiple time
points (week 0-6).
Separate variables of the composite change index include:
- 100 mm visual analogue scale: VAS subject*s assessment of pain
- Evaluation of functional disability of the treated joint, joint swelling and
joint tenderness (semi quantitative score, 0-3) by physician
- Patient*s and physician*s global assessment of the effect of therapy (semi
quantitative score, 0-3)
Secondary outcome
The secondary endpoints of this study are:
- Safety endpoints
- Acute phase reactants: Erythrocyte Sedimentation Rate (ESR) and C-Reactive
Protein (CRP)
- Immunogenicity parameters: serum etanercept levels, antibodies to etanercept
- 100 mm visual analogue scale: VAS subject*s assessment of disease activity
and VAS physician's global assessment of patient's current disease activity
- Joint assessments: DAS28, DAS68, Ritchie Articular Index
- Questionnaires: HAQ, SF-36, BASDAI
Background summary
TNF blockade is an effective therapeutic approach in rheumatoid arthritis,
ankylosing spondylitis and psoriatic arthritis. There is still an unmet need
for optimal local, intra-articular treatment in patients with monoarthritis or
oligoarthritis caused by this disease. Moreover, not all patients respond to
intra-articular corticosteroids or tolerate (intra-articular) corticosteroids.
Little is known about the effects of local treatment with etanercept, and
although initial studies have suggested safety of this approach, this has not
been tested in a randomized placebo-controlled setting.
Study objective
The primary objective is to determine if intra-articular etanercept therapy
reduces the clinical signs and symptoms of inflammatory arthritis and improve
outcome (beneficial effect). The secondary objective is to study safety and to
analyse immunogenicity parameters.
Study design
Monocenter, double-blind, randomized, placebo-controlled study with a follow-up
time of 6 weeks.
Intervention
One intra-articular injection of 25 mg etanercept (Enbrel®) or matching placebo
(NaCl 0.9%).
Study burden and risks
During this study patients are exposed to the risks associated with the use of
etanercept, injection site reactions being the most common reported adverse
event. Complications of the procedure (intra-articular injection) are very rare
and consist of infection of wound or the joint.
Patients are required to visit the hospital 7 times. During each visit the
patient will be asked to fill out questionnaires, blood will be taken and a
physical examination will be done.
Meibergdreef 9
1105 AZ Amsterdam ZO
Nederland
Meibergdreef 9
1105 AZ Amsterdam ZO
Nederland
Listed location countries
Age
Inclusion criteria
1.Provision of a written informed consent
2.Age range 18-85
3.Presence of active knee, ankle, wrist, elbow or MCP arthritis
4.Presence of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis
-Patients with RA for at least 3 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA
-Patients with AS or PsA for at least 3 months, diagnosed according to the modified New York criteria and CASPAR criteria respectively
Exclusion criteria
- Contra-indication for TNF-blockade or intra-articular treatment
- Bone or joint surgery 8 weeks prior to inclusion
- Arthroscopy within 2 weeks prior to inclusion, or arthroscopy planned during the time of the study
- Intra-articular or parenteral corticosteroids within 3 months prior to inclusion.
- Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily within 4 weeks prior to inclusion.
- Use of DMARDs other than methotrexate (MTX) within 4 weeks prior to inclusion.
- Receipt of a live vaccine within 4 weeks prior to randomization.
- Treatment with Etanercept (Enbrel) or any other form of systemic anti-TNFa therapy within 3 months prior to inclusion
- Known active bacterial, viral, fungal, mycobacterial or other infection (including tuberculosis, or atypical mycobacterial disease, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients with a positive PPD skin test should take isoniazide for at least 4 weeks before they can be included in the study.
- History of recurrent significant infection or history of recurrent bacterial infections.
- Primary or secondary immunodeficiency (history of, or currently active).
- Pregnant women or nursing (breastfeeding) mothers.
- History of cancer in the past 10 years, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured) or a history of cancer more than 10 years ago without curative treatment
- Sever heart, kidney, and/or lung disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006118-40-NL |
| CCMO | NL20331.018.07 |