Intraarticular Injection of Infliximab

NCT ID: NCT00521963

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

Conditions

Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

E

Group Type: EXPERIMENTAL

Intraarticular injection of infliximab

Intervention Type: BIOLOGICAL

A single injection of 100 mg of infliximab

Interventions

Intraarticular injection of infliximab

A single injection of 100 mg of infliximab

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: collaborator

Carmel Medical Center

OTHER

Sponsor Role: collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Principal Investigators

Reuven Mader, MD

Role: PRINCIPAL_INVESTIGATOR

Ha'Emek Medical Center, Afula, Israel

Locations

Bnai Zion Medical Center

Haifa, , Israel

Carmel Medical Center and Lin outpatient service

Haifa, , Israel

Countries

Israel

References

Schatteman L, Gyselbrecht L, De Clercq L, Mielants H. Treatment of refractory inflammatory monoarthritis in ankylosing spondylitis by intraarticular injection of infliximab. J Rheumatol. 2006 Jan;33(1):82-5. Epub 2005 Nov 15.

Reference Type: BACKGROUND

PMID: 16292792 (View on PubMed)

Conti F, Priori R, Chimenti MS, Coari G, Annovazzi A, Valesini G, Signore A. Successful treatment with intraarticular infliximab for resistant knee monarthritis in a patient with spondylarthropathy: a role for scintigraphy with 99mTc-infliximab. Arthritis Rheum. 2005 Apr;52(4):1224-6. doi: 10.1002/art.20979.

Reference Type: BACKGROUND

PMID: 15818709 (View on PubMed)

Nikas SN, Temekonidis TI, Zikou AK, Argyropoulou MI, Efremidis S, Drosos AA. Treatment of resistant rheumatoid arthritis by intra-articular infliximab injections: a pilot study. Ann Rheum Dis. 2004 Jan;63(1):102-3. doi: 10.1136/ard.2003.006981. No abstract available.

Reference Type: BACKGROUND

PMID: 14672902 (View on PubMed)

Other Identifiers

0088-07-EMC

Identifier Type: -

Identifier Source: org_study_id