Clinical trial: Subject Insights to Understand the Hand Osteoarthritis (HOA) (NCT03271203)

Eligibility criteria:
Inclusion Criteria:

        Inclusion Criteria for Erosive Hand OA

          -  Subject is a male or female between 40-80 years of age (inclusive) at the time of
             signing the informed consent form.

          -  Subject meets the American College of Rheumatology (ACR) classification of
             osteoarthritis: Hand pain, aching, or stiffness and 3 or 4 of the following features:
             Hard tissue enlargement of 2 or more of 10 selected joints, Hard tissue enlargement of
             2 or more distal interphalangeal (DIP) joints, Fewer than 3 swollen
             metatarsophalangeal (MCP) joints or Deformity of at least 1of 10 selected joints where
             The 10 selected joints are the second and third DIP, the second and third proximal
             interphalangeal (PIP), and the first carpometacarpal joints of both hands.

          -  Subject has erosive disease on at least 1 PIP or 1DIP joint as demonstrated by imaging
             evidence [can include X-ray, ultrasound or magnetic resonance imaging (MRI) evidence].

          -  Subject has active disease in at least one hand, with at least two soft tissue swollen
             and tender PIP and/or DIP joints in the affected hand by clinical examination within
             the past 3 months. If only one hand is affected by HOA and meets the inclusion
             criteria, the affected hand should be documented at screening and used for all
             assessments. In cases where both hands are affected by HOA and both meet the inclusion
             criteria, then the dominant hand should be documented at screening and used for all
             assessments.

          -  Subject's self-reported average hand-pain intensity over the past 7 days must be at
             least '4' on a 0-10 Numerical Rating Scale (NRS).

          -  Subject must have negative titer rheumatoid factor (RF) and anti- Cyclic Citrullinated
             Peptide (CCP) antibody.

          -  Subject must have a personally signed and dated written informed consent form prior to
             admission to the study.

          -  Subject must be verbally fluent and literate in English.

          -  Subject must be able to attend and participate in two 45 minute telephone or video
             call (Skype or Facetime) interviews (either on the same day or separate days).

        Inclusion Criteria for Non-Erosive Hand OA

          -  Subject is a male or female between 40-80 years of age (inclusive) at the time of
             signing the informed consent form

          -  Subject meets the American College of Rheumatology (ACR) classification of
             osteoarthritis: Hand pain, aching, or stiffness and 3 or 4 of the following features:
             Hard tissue enlargement of 2 or more of 10 selected joints, Hard tissue enlargement of
             2 or more distal interphalangeal (DIP) joints, Fewer than 3 swollen
             metacarpophalangeal (MCP) joints, Deformity of at least 1 of 10 selected joints where
             the 10 selected joints are the second and third distal interphalangeal (DIP), the
             second and third proximal interphalangeal, and the first carpometacarpal joints of
             both hands.

          -  Subject has at least 1 finger joint (DIP or PIP) with K-L ≥ 2 [by x-ray in last 12m].
             Participant's self-reported average hand-pain intensity over the past 7 days must be
             moderate to severe (≥4 on a 0-10 Numeric Rating Scale [NRS] or ≥40mm on a 0-100mm
             Visual Analog Scale [VAS]). If only one hand is affected by hand osteoarthritis (HOA)
             and meets the inclusion criteria, the affected hand should be documented at screening
             and used for all assessments. In cases where both hands are affected by HOA and both
             meet the inclusion criteria, then the dominant hand should be documented at screening
             and used for all assessments.

          -  Subject is unwilling or unable to take non-opiate analgesics, or is inadequately
             controlled by non-opiate analgesics (non-opiate analgesics include Tramadol)

          -  Subject must have negative titer rheumatoid factor (RF) and anti-CCP antibody

          -  Subject must have a personally signed and dated written informed consent form prior to
             admission to the study

          -  Subject must be verbally fluent and literate in English

          -  Subject must be able to attend and participate in two 45 minute telephone or video
             call (Skype or Facetime) interviews (either on the same day or separate days)

        Inclusion criteria for subjects taking part in real-time data capture:

          -  Subject owns/or has access to either a smartphone [iPhone Operating System (iOS) or
             android] or tablet which has video, audio/microphone and photographic capabilities and
             access to either the Apple app store or Google play store to download the app.

          -  Subject is willing and able to take part in the real time data application task and
             respond to a series of questions/tasks fielded via the application over the course of
             seven days.]

          -  Subject would feel comfortable recording short videos of themselves and providing
             audio commentary in response to app questions/tasks.

        Exclusion Criteria:

        Exclusion Criteria for Erosive Hand OA

          -  Subject has history of any clinically significant inflammatory disease other than
             inflammatory osteoarthritis, especially, but not limited to, rheumatoid arthritis or
             spondylarthropathies.

          -  Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium
             pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other
             inflammatory rheumatological or autoimmune disorders.

          -  Subject has had a clinical suspicion of, or previous investigation for CPPD or
             pseudogout, or history of chondrocalcinosis.

          -  Subject has any injury, medical or surgical procedure to the affected joint(s) that
             may interfere with evaluation of the target hand osteoarthritis joint(s).

          -  Subject has great difficulty hearing, reading or speaking.

          -  Subject has an uncontrolled psychiatric condition (example, schizophrenia,bipolar
             disorder) or mental condition rendering the subject unable to understand the nature,
             scope, and possible consequences of the study or likely to have difficulty
             participating in two 45 minute interviews.

          -  Subject has severe physical, neurological or cognitive deficits that might prohibit
             the ability to participate in an interview about the experience of their hand
             osteoarthritis and completion of a questionnaire.

          -  Subject is currently or has previously been enrolled in a clinical trial for OA in the
             past 6 months.

        Exclusion Criteria for Non-Erosive Hand OA

          -  Subject has erosive disease on any proximal interphalangeal (PIP) or distal
             interphalangeal (DIP) joints as evidenced via X-ray, MRI or ultrasound

          -  Subject has history of any clinically significant inflammatory disease other than
             inflammatory osteoarthritis, especially, but not limited to, rheumatoid arthritis or
             spondylarthropathies

          -  Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium
             pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other
             inflammatory rheumatological or autoimmune disorders

          -  Subject has had a clinical suspicion of, or previous investigation for CPPD or
             pseudogout, or history of chondrocalcinosis

          -  Subject has any injury, medical or surgical procedure to the affected joint(s) that
             may interfere with evaluation of the target hand osteoarthritis joint(s)

          -  Subject has great difficulty hearing, reading or speaking

          -  Subject has an uncontrolled psychiatric condition (e.g., schizophrenia, bipolar
             disorder) or mental condition rendering the patient unable to understand the nature,
             scope, and possible consequences of the study or likely to have difficulty
             participating in two 45 minute interviews

          -  Subject has severe physical, neurological or cognitive deficits that might prohibit
             the ability to participate in an interview about the experience of their hand
             osteoarthritis and completion of a questionnaire

          -  Subject is currently or has previously been enrolled in a clinical trial for hand OA
             in the past six months
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.
Subject must be at most 80 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment