Adalimumab for Inflammatory Osteoarthritis

NCT00686439 | Completed Phase 1

• 1 other identifier: HUM 06-087
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.

Conditions

Osteoarthritis

Keywords

osteoarthritis; adalimumab; mri

Outcome Measures

Primary Outcomes (1)

• OARSI/OMERACT response

  12 weeks

Secondary Outcomes (1)

• WOMAC Patient Global MRI

  12 weeks

Study Arms (1)

adalimumab

EXPERIMENTAL

Drug: adalimumab

Interventions

adalimumab DRUG

subcutaneous injection 40mg on alternate weeks

Also known as: Humira

adalimumab

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 40 years of age or older.
• If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
• If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
• Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
• Patient has had daily knee pain for the month preceding study enrolment.
• Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee.
• Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.

You may not qualify if:

• Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
• Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
• Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
• Patient has predominant patellofemoral disease

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

The University of Alberta Hospital

Edmonton, Alberta, T6G-2B7, Canada

Location

Related Publications (1)

• Maksymowych WP, Russell AS, Chiu P, Yan A, Jones N, Clare T, Lambert RG. Targeting tumour necrosis factor alleviates signs and symptoms of inflammatory osteoarthritis of the knee. Arthritis Res Ther. 2012 Oct 4;14(5):R206. doi: 10.1186/ar4044.

  PMID: 23036475 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• walter p maksymowych, FRCP

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: F.R.C.P.(C),Professor of Medicine, Consultant Rheumatologist

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

CA (1)