Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) (BIORA-PAIN)

Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Abatacept Injection; Drug: Adalimumab Injection

Detailed Description

Primary objective To examine: Pain characteristics in participants with active rheumatoid arthritis receiving abatacept biologic therapy versus TNF inhibitor therapy in the form of adalimumab.

To establish if there are differences in pain outcomes by patient reported scores, objective measures of pain using quantitative sensory testing and inflammatory markers in participants receiving biologic therapies for rheumatoid arthritis.

Population: The population being assessed in this study are participants with active rheumatoid arthritis with a disease activity score of greater than 5.1.

Intervention: Subjects will be randomized to treatment with abatacept or adalimumab for active rheumatoid arthritis

Comparison group: Abatacept is being compared to adalimumab therapy in the trial

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Prof Sofat, MD, PhD; Phone Number: 004402087251419; Email: nsofat@sgul.ac.uk
• Study Contact Backup: Name: Ms Koushesh, BSc, MSc; Phone Number: 004402082666474; Email: skoushes@sgul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 OPQ
    • Hotung Centre for Musculoskeletal Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abatacept; Drug administered to participants with active rheumatoid arthritis	Drug: Abatacept Injection; Subjects will be randomized to treatment with either abatacept or adalimumab; Other Names: Orencia
Active Comparator: Adalimumab; Comparator drug administered to participants with active rheumatoid arthritis	Drug: Adalimumab Injection; Subjects will be randomized to treatment with either abatacept or adalimumab; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood markers	Pain biomarkers in serum	0, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: St George's, University of London
• Investigators: Principal Investigator: Prof Sofat, MD, PhD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Adalimumab; Abatacept
• Other Study ID Numbers: 2019.0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Published data will be reported in publications from the trial. Data will be shared with other researchers on written request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No