Central Aspects of Pain in Rheumatoid Arthritis

NCT04515589

Last updated date
Study Location
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield, Nottinghamshire, , United Kingdom
Contact
+441153231810

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

+441153231810

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult (age≥18y) of any sex and ethnicity.

- Satisfy EULAR criteria for RA.

- Active RA, as defined as DAS28 ≥3.2 at baseline visit

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unable to give informed consent.


- Insufficient understanding of spoken or written English to comply with the
requirements of the study protocol


- Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house,
terminal diagnosis, current or planned pregnancy).


- Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring
changes in medical treatment at baseline


- Major active psychiatric condition (e.g. major depression)


- Inability to meet the requirements of clinical assessments

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Rheumatoid ArthritisCONfident Treatment Decisions in Living With Rheumatoid Arthritis
NCT03317756
  1. Birmingham, Alabama
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisEffect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
NCT03755297
  1. Montpellier,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Rheumatoid ArthritisRheumatoid Arthritis DMARD Intervention and UtilizationStudy
NCT00116727
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Central Aspects of Pain in Rheumatoid Arthritis
Official Title Central Aspects of Pain in Rheumatoid Arthritis
Brief Summary This study seeks to measure the psychometric properties of a newly developed Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA) questionnaire, and investigate the ability of this questionnaire to measure central mechanisms of pain and also to predict worse pain and fatigue outcomes in people with Rheumatoid Arthritis (RA).
Detailed Description

Persistent pain and fatigue are prevalent and disabling symptoms in people with Rheumatoid Arthritis, even in the absence of active inflammation. The investigators believe that these symptoms may be a result of abnormal pain processing by the Central Nervous System (CNS), in a process called central sensitization.

The investigators have developed a short, self-report questionnaire to measure central pain mechanisms in people with RA. It is called Central Aspects of Pain in Rheumatoid Arthritis (CAP-RA), and was adapted from a pre-existing questionnaire called CAP-Knee (which measures central sensitization in people with chronic knee pain).

This study aims to measure the psychometric properties of CAP-RA, and the ability of the questionnaire to predict worse pain in the RA population. Secondary objectives of the study include predicting worse fatigue in people with RA, deriving CAP-RA scoring recommendations, investigating other factors associated with persistent RA pain, the association between central sensitization and pain, and investigating the course of pain and fatigue in RA.

Participants will be recruited from a Rheumatology clinic. At baseline and 12 weeks these participants will undergo quantitative sensory testing (QST, pain tests), ultrasound for synovitis, clinical assessments, laboratory tests for systemic inflammation and, complete a questionnaire booklet, including the CAP-RA questionnaire.

Some participants will complete the CAP-RA questionnaire 1 week after the baseline visit to assess the test-retest reliability of the questionnaire.

In addition, participants will provide weekly pain and fatigue self-report via SMS for 12 weeks.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population The study population will include people with Rheumatoid Arthritis receiving care at the Kings Mill Hospital, Sherwood Forest NHS Foundation Trust, Nottinghamshire, UK, who meet the eligibility criteria.
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Main study cohort
The main study cohort in this single-arm cohort is 250 adults with rheumatoid arthritis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 14, 2020)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult (age?18y) of any sex and ethnicity.
  • Satisfy EULAR criteria for RA.
  • Active RA, as defined as DAS28 ?3.2 at baseline visit

Exclusion Criteria:

  • Unable to give informed consent.
  • Insufficient understanding of spoken or written English to comply with the requirements of the study protocol
  • Unable or unlikely to complete the proposed 12-week study follow up (eg. moving house, terminal diagnosis, current or planned pregnancy).
  • Active comorbidity (e.g. uncontrolled diabetes mellitus, cancer, infection) requiring changes in medical treatment at baseline
  • Major active psychiatric condition (e.g. major depression)
  • Inability to meet the requirements of clinical assessments
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Onosi S Ifesemen+441153231810[email protected]
Contact: Daniel F McWilliams+441153231942[email protected]
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04515589
Other Study ID Numbers 20001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:Undecided
Plan Description:Pre-planned analyses will be performed by the study team. Requests for collaborative analyses of IPD, using non-identifiable data, may be made to the study PI.
Responsible Party University of Nottingham
Study Sponsor University of Nottingham
Collaborators
  • Versus Arthritis
  • Pfizer
Investigators
Principal Investigator:David A WalshUniversity of Nottingham
PRS Account University of Nottingham
Verification Date August 2020