Clinical trial: Adalimumab for Inflammatory Osteoarthritis (NCT00686439)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1