OsteoarthritisNCT03271203

Subject Insights to Understand the Hand Osteoarthritis (HOA)

An observational study of Osteoarthritis, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis
What is being tested?: Michigan Hand Outcomes Questionnaire and Real-time data capture app
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: 3 Jul 2017to 30 Oct 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

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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 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.

Who cannot join

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.

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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
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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Bollington, Cheshire, SK10 5JB

Other trials in United Kingdom

About this study

Official title: Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Hand Osteoarthritis

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
Being tested: Michigan Hand Outcomes Questionnaire, Real-time data capture app
Keywords: Michigan Hand Outcomes Questionnaire, Real-time data capture, Cognitive debriefing, Hand Osteoarthritis, Concept elicitation
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Michigan Hand Outcomes QuestionnaireOther
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.
Real-time data capture appOther
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.

Study groups in NCT03271203
Study group	Role	What they receive
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. Receives: 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 Receives: Other: Michigan Hand Outcomes Questionnaire; Other: Real-time data capture app

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Secondary outcomes (3)

Content validity of the Michigan Hand Outcomes Questionnaire through CD interviews
The MHQ is a self-report measure that assesses the function of 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 a pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance. Subjects will be asked to complete the MHQ questionnaire during CD interview using a 'think-aloud' technique to evaluate the content validity.
Measured: 1 day
Analysis of hand osteoarthritis experience by using real-time data data capture task
A subgroup of ten of the thirty subjects participating in the CE and CD interviews will be asked to take part in the real-time data capture task over the course of 7 days and during this time a series of questions/tasks will be asked to subjects via the application to explore the experience of the symptoms, HRQoL impacts and treatment of erosive HOA and any day-to-day variability that exists these experiences in 'real time'.
Measured: Up to 7 days
Preparation of conceptual model
Data obtained from the CE and CD interviews as well as real-time data capture will be used to develop a conceptual model for erosive HOA. Symptom, impact, and treatment concepts which have been identified will be grouped into domains and displayed visually and any identified relationships or trends between domains will also be included in the model. A key will be developed using color coding or bolding/italics to show the source of the concept (example, red if the concept emerged from the interviews only, and green it emerged from the real-time data capture only). In addition, and where relevant the frequency at which a concept was reported across sources will be included in the model.
Measured: Up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201730 Oct 2017

First posted5 Sep 2017
Study start3 Jul 2017
Primary completion30 Oct 2017
Study completion30 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03271203
Sponsor's protocol ID: 206599
Status last verified: Oct 2018
First submitted: 29 Jun 2017
Last updated: 16 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Hand Osteoarthritis
ClinicalTrials.gov ID: NCT03271203
Acronym / sponsor ID: 206599
Conditions: Osteoarthritis
Keywords: Michigan Hand Outcomes Questionnaire, Real-time data capture, Cognitive debriefing, Hand Osteoarthritis, Concept elicitation
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 3 Jul 2017 (actual)
Primary completion: 30 Oct 2017 (actual)
Study completion: 30 Oct 2017 (actual)
First posted: 5 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Subjects participating in the CE and CD interview	–	Other: Michigan Hand Outcomes QuestionnaireThirty adult subjects from the US with erosive HOA will be asked to participate in CE and CD interviews.
Subjects participating in interview and real time data capture	–	Other: Michigan Hand Outcomes Questionnaire, Other: Real-time data capture appTen 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

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Thirty adult US-English speaking subjects with erosive HOA will be included in this study.

Key inclusion criteria (21 listed)

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).

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Michigan Hand Outcomes QuestionnaireThe 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.	Other	Subjects participating in interview and real time data capture, Subjects participating in the CE and CD interview
Real-time data capture appReal 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.	Other	Subjects participating in interview and real time data capture

Primary outcome

Number of subjects with hand osteoarthritis participating in CE interviews
Time frame: 1 day
CE interviews will be carried out to explore disease experience with respect to symptoms, impacts and treatment/surgical experiences.

3 secondary outcomes

Content validity of the Michigan Hand Outcomes Questionnaire through CD interviews
Time frame: 1 day
Analysis of hand osteoarthritis experience by using real-time data data capture task
Time frame: Up to 7 days
Preparation of conceptual model
Time frame: Up to 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Results for study 206599 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

Related trials for Osteoarthritis

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with hand osteoarthritis participating in CE interviews (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271203.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.