Subject Insights to Understand the Hand Osteoarthritis (HOA)

NCT03271203 | Completed

• 1 other identifier: 206599
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Michigan Hand Outcomes Questionnaire; Real-time data capture; Cognitive debriefing; Hand Osteoarthritis; Concept elicitation

Outcome Measures

Primary Outcomes (1)

• Number of subjects with hand osteoarthritis participating in CE interviews

  CE interviews will be carried out to explore disease experience with respect to symptoms, impacts and treatment/surgical experiences.

  1 day

Secondary Outcomes (3)

• Content validity of the Michigan Hand Outcomes Questionnaire through CD interviews

  1 day

• Analysis of hand osteoarthritis experience by using real-time data data capture task

  Up to 7 days

• Preparation of conceptual model

  Up to 7 days

Study Arms (2)

Subjects participating in the CE and CD interview

Thirty adult subjects from the US with erosive HOA will be asked to participate in CE and CD interviews.

Other: Michigan Hand Outcomes Questionnaire

Subjects participating in interview and real time data capture

Ten adult subjects from the US (n=5 with erosive HOA, n=5 with non-erosive HOA) of the thirty subjects who are participating in the CE and CD interviews, will be asked to participate in the real-time data capture app task

Other: Michigan Hand Outcomes Questionnaire; Other: Real-time data capture app

Interventions

Michigan Hand Outcomes Questionnaire OTHER

The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.

Subjects participating in interview and real time data capture; Subjects participating in the CE and CD interview

Real-time data capture app OTHER

Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms.

Subjects participating in interview and real time data capture

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thirty adult US-English speaking subjects with erosive HOA will be included in this study.

You may qualify if:

• 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'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).
• 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 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bollington, Cheshire, SK10 5JB, United Kingdom

Location

Related Links

• Results for study 206599 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: September 5, 2017
• Study Start: July 3, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

GB (1)