Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

NCT04255134 | Completed Phase 4 DMC

• 1 other identifier: 2019.0146
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

It is increasingly recognized that although suppression of inflammation is a treatment goal in rheumatoid arthritis, many people who have control of their inflammation continue to experience pain. A number of studies have recently shown that by measuring further characteristics of pain in rheumatoid arthritis, e.g. neuropathic pain, quantitative sensory testing, compared with objective measures of inflammation, it is possible to acquire more detailed information about the level of pain in relation to inflammation that a patient with rheumatoid arthritis is experiencing, which could assist in developing their care. In this study, the investigators will explore validated endpoints for pain including the Visual Analogue Scale for pain, neuropathic pain scores and quantitative sensory testing for pain. The investigators will evaluate in a population-based study, the pain profile using the Visual Analog Scale (VAS), neuropathic pain assessment, quantitative sensory testing (QST) by pain pressure thresholds (PPT) in comparison to markers of inflammation in order to assess the difference in pain outcomes between baseline pre- and post- treatment in a population of participants with active Rheumatoid Arthritis treated with abatacept and Tumor Necrosis Factor (TNF) inhibitors respectively. All measures will be conducted systematically in the abatacept and TNF inhibitor groups pre- and post-treatment with respective biologic agents. Participants with active Rheumatoid Arthritis who may be eligible for biologic treatment will be screened for enrolment into the study.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Change in the Visual Analogue Score for Pain

  The Visual Analogue Score for Pain is a pain score which has a numerical rating scale from 0 to 10

  0, 3, 6, 9, 12 months

• Change in the Neuropathic pain questionnaire: PainDETECT

  The painDETECT pain questionnaire is a numerical rated score for neuropathic pain

  0, 3, 6, 9, 12 months

• Change in Quantitative sensory testing

  Quantitative sensory testing measures numerical values for pain in specific regions of testing

  0, 3, 6, 9, 12 months

Secondary Outcomes (1)

• Change in Blood markers

  0, 3, 6, 9, 12 months

Study Arms (2)

Abatacept

EXPERIMENTAL

Drug administered to participants with active rheumatoid arthritis

Drug: Abatacept Injection

Adalimumab

ACTIVE COMPARATOR

Comparator drug administered to participants with active rheumatoid arthritis

Drug: Adalimumab Injection

Interventions

Abatacept Injection DRUG

Subjects will be randomized to treatment with either abatacept or adalimumab

Also known as: Orencia

Abatacept

Adalimumab Injection DRUG

Subjects will be randomized to treatment with either abatacept or adalimumab

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active rheumatoid arthritis causing pain and functional impairment with DAS28 \>5.1 -Has already received usual care for inflammatory arthritis including conventional DMARD therapy e.g. methotrexate, sulfasalazine, leflunomide, hydroxychloroquine on stable dose of csDMARD for at least 4 weeks prior to study drug initiation
• Willing to participate in the study over a 12-month period
• Desirably to have positive antibodies to cyclic citrullinated peptide (ACPA/CCP)
• Between 18 and 75 years of age

You may not qualify if:

• Pregnancy or pregnancy planned over next 12 months
• Current or previous unsuccessful use of the biologics abatacept or adalimumab
• Co-existing other autoimmune condition, e.g. systemic lupus erythematosus, -Sjogren's syndrome, connective tissue disease, fibromyalgia, osteoarthritis, gout
• Recent surgery in the last 3 months or imminent surgery in the next 12 months
• Unable to give informed consent
• Previous history of cancer in the last 5 years
• Previous history of multiple sclerosis
• Uncontrolled heart failure, hypertension or diabetes mellitus
• Known history of fibromyalgia or other chronic pain disorder

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

Hotung Centre for Musculoskeletal Diseases

London, SW17 OPQ, United Kingdom

Location

Related Publications (1)

• Ahmed L, Biddle K, Blundell A, Koushesh S, Kiely P, Mein G, Sedgwick P, Sofat N. Assessing the effects of distinct biologic therapies on rheumatoid arthritis pain by nociceptive, neuropathic and nociplastic pain components: a randomised feasibility study. Pilot Feasibility Stud. 2024 May 16;10(1):77. doi: 10.1186/s40814-024-01505-4.

  PMID: 38755699 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Immunoproteins

Study Officials

• Prof Sofat, MD, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a randomized, open label trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: February 5, 2020
• Study Start: September 7, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)