Intraarticular Injection of Infliximab

NCT00521963 | Withdrawn Phase 2

• 1 other identifier: 0088-07-EMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Intraarticular injection; Infliximab

Outcome Measures

Primary Outcomes (1)

• suppression of inflammation

  12 weeks

Secondary Outcomes (1)

• Amount of systemic absorbtion

  2,4,8,12weeks

Study Arms (1)

E

EXPERIMENTAL

Biological: Intraarticular injection of infliximab

Interventions

Intraarticular injection of infliximab BIOLOGICAL

A single injection of 100 mg of infliximab

Also known as: Remicade

E

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have non-infectious monoarthritis of the knee and with inadequate response to IA injection of corticosteroids, at least 3 months before enrollment.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Bnai Zion Medical Center: collaborator
• Carmel Medical Center: collaborator

Study Sites (2)

Bnai Zion Medical Center

Haifa, Israel

Location

Carmel Medical Center and Lin outpatient service

Haifa, Israel

Location

Related Publications (3)

• 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.

  PMID: 16292792 BACKGROUND

• 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.

  PMID: 15818709 BACKGROUND

• 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.

  PMID: 14672902 BACKGROUND

MeSH Terms

Conditions

Arthritis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Reuven Mader, MD

  Ha'Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2007
• First Posted: August 28, 2007
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

IL (2)