Intraarticular Injection of Infliximab

Arthritis Clinical Trial

Official title:

Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00521963
• Other study ID #: 0088-07-EMC
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: August 17, 2007
• Last updated: June 25, 2015
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-a or other biologic agents

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

Biological:
• Intraarticular injection of infliximab
A single injection of 100 mg of infliximab

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa
Israel	Carmel Medical Center and Lin outpatient service	Haifa

Sponsors (3)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	Bnai Zion Medical Center, Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	suppression of inflammation		12 weeks
Secondary	Amount of systemic absorbtion		2,4,8,12weeks