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Intraarticular Injection of Infliximab

Primary Purpose

Arthritis

Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Intraarticular injection of infliximab
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Intraarticular injection, Infliximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bnai Zion Medical Center
  • Carmel Medical Center and Lin outpatient service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E

Arm Description

Outcomes

Primary Outcome Measures

suppression of inflammation

Secondary Outcome Measures

Amount of systemic absorbtion

Full Information

First Posted
August 17, 2007
Last Updated
June 25, 2015
Sponsor
HaEmek Medical Center, Israel
Collaborators
Bnai Zion Medical Center, Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00521963
Brief Title
Intraarticular Injection of Infliximab
Official Title
Interventional Study: Administration of Intraarticular Injection of Infliximab in Patients With Inflammatory Arthritis Who Failed Intraarticular Injection of Corticosteroids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
poor accrual
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
HaEmek Medical Center, Israel
Collaborators
Bnai Zion Medical Center, Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
Intraarticular injection, Infliximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Intraarticular injection of infliximab
Other Intervention Name(s)
Remicade
Intervention Description
A single injection of 100 mg of infliximab
Primary Outcome Measure Information:
Title
suppression of inflammation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Amount of systemic absorbtion
Time Frame
2,4,8,12weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reuven Mader, MD
Organizational Affiliation
Ha'Emek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Carmel Medical Center and Lin outpatient service
City
Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
16292792
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.
Results Reference
background
PubMed Identifier
15818709
Citation
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.
Results Reference
background
PubMed Identifier
14672902
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. doi: 10.1136/ard.2003.006981. No abstract available.
Results Reference
background

Learn more about this trial

Intraarticular Injection of Infliximab

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