Pain in Inflammatory Joint Diseases

NCT06718569 | Recruiting

• 2 other identifiers: DS-00850708967
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory joint diseases, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.

Conditions

Arthritis, Juvenile Idiopathic; Arthritis, Reactive; Arthritis, Psoriatic; Spondyloarthritis (SpA); Arthritis; Arthritis,Rheumatoid

Outcome Measures

Primary Outcomes (1)

• PROMIS Pain Interference - Short Form 8a

  PROMIS Pain Interference - Short Form 8a assesses to which extend pain affect various aspects in daily life. This includes 8 items covering social, emotional, physical, and recreational activities \[74\], such as "How much did pain interfere with your day-to-day activities?" and "How much did pain interfere with your enjoyment of life?". The items have a 7-day time frame. Participants are asked to rate their responses on a three different 5-point Likert response scales. Scores are converted to a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD). Higher scores represent more pain interference.

  Baseline, 3 months

Secondary Outcomes (23)

• Social network

  Baseline

• Gender role perception

  Baseline

• Arthritis Self-Efficacy Scale (ASES)

  Baseline

• Pain Catastrophizing Scale (PSC)

  Baseline

• Douleur Neuropathique 4 (DN4)

  Baseline and 3 months

Study Arms (1)

Patients who initiate or switch biological or targeted synthetic DMARD

All patients initiate or switch biological or targeted synthetic DMARD

Drug: Biological or targeted synthetic DMARD

Interventions

Biological or targeted synthetic DMARD DRUG

All biological or targeted synthetic DMARDs that are available for treatment of patients with inflammatory joint diseases

Patients who initiate or switch biological or targeted synthetic DMARD

Eligibility Criteria

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

Study Population

The study population consists of men and women (\>18 years of age at screening) who are enrolled in the Nor-DMARD register and give their consent to also participate in this sub-study. We will not have other inclusion and exclusion criteria than those that are already part of the Nor-DMARD register. This means that all patients who are being enrolled in the Nor-DMARD register will be asked to be part of this sub-study.

You may qualify if:

• All patients who initiate or switch biological or targeted synthetic DMARDs

You may not qualify if:

• None

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect three extra tubes of blood (one for EDTA tube for whole blood, one EDTA tube for plasma and one for serum- each tube with 2 ml of blood), that will be used in this sub-study. The samples will be stored in a certified biobank in a freezer at -70° C. They will be used for research purposes only and may include analysis of potential new biomarkers of disease activity or outcomes including deoxyribonucleic and ribonucleic acid analyses (genomics and transcriptomics), proteins, enzymes, signalling molecules and metabolites in the blood. Only genetic markers and sequences that are prevalent in the population or that have been associated with disease, disease-related symptoms or risk factors will be tested. Since these diseases are complex diseases with an interplay of several genes (each with only small effects) and other risk factors, patients will not be informed about the results.

MeSH Terms

Conditions

Arthritis; Arthritis, Juvenile; Arthritis, Rheumatoid; Arthritis, Reactive; Arthritis, Psoriatic; Spondylarthritis

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Infectious; Infections; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Ida K Haugen, MD PhD

CONTACT

+47 95859884; ida.k.haugen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NO (1)