Intraarticular Injection of Infliximab
Recruitment status was Not yet recruiting
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Purpose
Intra-articular (IA) injection of medication is a common procedure in the management of joint disorders. In particular, the procedure is effective in the treatment of inflammatory conditions, with long acting corticosteroids most commonly used. These agents have been shown to reduce the signs and symptoms of inflammation, expressed primarily in the synovium of the joint, and are probably capable of slowing the progression of damage to joint cartilage and bone in some of these inflammatory conditions. Arthritis that is refractory to IA corticosteroid injections may respond to surgical, chemical, or, radioisotope synovectomy, procedures in which the inflamed synovial tissue is eradicated. It has been noted that infliximab, a monoclonal antibody directed to Tumor Necrosis Factor (TNF) - α, has high affinity for the TNF-α rich inflamed synovium. Recently, clinical benefit from IA injections of infliximab has been reported in some cases that were refractory to IA injections of corticosteroids. Similarly, the effectiveness of IA infliximab in suppression of joint inflammation has also been demonstrated in patients who could not receive systemic therapy with infliximab. These reports examined the effect of a single injection of infliximab100 mg injected into a large inflamed joint or 2 IA injections 24 hours apart.
We propose to further evaluate the use of IA infliximab in patients with intractable knee monoarthritis, explore the optimal mode of its employment, and assess the degree of infliximab systemic absorption from the IA injection. In a pilot study 40 knees will be evaluated, 20 injected with infliximab and 20 injected with a corticosteroid comparator reflecting the current standard of care.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis |
Biological: Intraarticular injection of infliximab |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids |
- suppression of inflammation [ Time Frame: 12 weeks ]
- Amount of systemic absorbtion [ Time Frame: 2,4,8,12weeks ]
| Estimated Enrollment: | 40 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E |
Biological: Intraarticular injection of infliximab
A single injection of 100 mg of infliximab
Other Name: Remicade
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have non-infectious monoarthritis of the knee and with inadequate response to IA injection of corticosteroids, at least 3 months before enrollment.
or
- Have oligo or polyarthritis controlled by disease modifying agents (DMARDs) but with residual 1-2 inflamed joints, one of which is a knee with inadequate response to IA injection of corticosteroids within 3 months
- Have negative PPD skin test.
- Have no evidence of TB on chest x-ray.
- Be negative for HBsAg and HCV.
- No evidence of infectious arthritis
Exclusion Criteria:
- Known allergy to infliximab.
- Known allergy to lidocaine.
- Pregnant.
- Female patients with childbearing potential who do not practice effective methods of contraception.
- Suffer from a chronic infection.
- On systemic anti TNF-α or other biologic agents
Contacts and Locations| Contact: Reuven Mader, MD | 972-4-6494354 | Mader_r@clalit.org.il |
| Israel | |
| Bnai Zion Medical Center | Not yet recruiting |
| Haifa, Israel | |
| Contact: Itzchak Rosner, MD 972-4-6420056 rosneri@techunix.technion.ac.il | |
| Principal Investigator: Itzchak Rosner, MD | |
| Carmel Medical Center and Lin outpatient service | Not yet recruiting |
| Haifa, Israel | |
| Contact: Devi Zisman, MD 972-0506265526 devyzi@clalit.org.il | |
| Principal Investigator: Devi Zisman, MD | |
| Principal Investigator: | Reuven Mader, MD | Ha'Emek Medical Center, Afula, Israel |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00521963 History of Changes |
| Other Study ID Numbers: | 0088-07-EMC |
| Study First Received: | August 17, 2007 |
| Last Updated: | August 27, 2007 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by HaEmek Medical Center, Israel:
|
Intraarticular injection Infliximab |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases Infliximab Dermatologic Agents |
Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013