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Adalimumab for Inflammatory Osteoarthritis

Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: adalimumab (Drug); adalimumab (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: University of Alberta

Official(s) and/or principal investigator(s):
walter p maksymowych, FRCP, Principal Investigator, Affiliation: University of Alberta

Summary

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

Clinical Details

Official title: HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: OARSI/OMERACT response

Secondary outcome: WOMAC Patient Global MRI

Detailed description: This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 continual pain for at least 6 months prior to inclusion in the study.

This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month: acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i. e. Tylenol No 2, 3, 4) taken at least 3 times daily

- 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. Exclusion Criteria:

- 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

Locations and Contacts

The University of Alberta Hospital, Edmonton, Alberta T6G-2B7, Canada
Additional Information

Starting date: June 2008
Last updated: June 12, 2012

Page last updated: August 23, 2015

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