Clinical trial NCT03271203: Subject Insights to Understand the Hand Osteoarthritis (HOA)
Official title: Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Hand Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Michigan Hand Outcomes Questionnaire
Real-time data capture
Cognitive debriefing
Hand Osteoarthritis
Concept elicitation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty adult US-English speaking subjects with erosive HOA will be included in this study.

Brief summary: Osteoarthritis (OA) is a degenerative joint disease which causes joints to become painful and stiff. HOA is the second most common form of OA and is characterized by stiffness, joint pain and inflammation and tenderness in the knuckles or around the waist. This cross-sectional, qualitative interview study aims to explore the experience of erosive HOA as well as explore the content validity of the Michigan Hand Outcomes Questionnaire (MHQ) by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The conceptual model developed from this data will be used to support the development of GSK3196165, a human monoclonal antibody target for the treatment of HOA. The CE interviews (45 minutes duration) will explore the experience of subjects suffering with HOA and will collect information about symptoms, health related quality of life (HRQoL), treatment experience and the language used by subjects to describe them whereas the CD interviews (45 minutes duration) will assess the content validity of the MHQ. The real-time disease experience of subjects will be captured by the real-time data capture app-based activity over a period of 7 days. Approximately 30 subjects from the United States (US) of which 15 subjects will be erosive HOA and rest 15 will be non-erosive HOA.


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

Primary outcomes:
measure: Number of subjects with hand osteoarthritis participating in CE interviews
timeFrame: 1 day
Secondary outcomes:
measure: Content validity of the Michigan Hand Outcomes Questionnaire through CD interviews
timeFrame: 1 day
measure: Analysis of hand osteoarthritis experience by using real-time data data capture task
timeFrame: Up to 7 days
measure: Preparation of conceptual model
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Bollington
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: