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Completed

NCT Number: NCT04157010

Tocilizumab REMission in Early RA

The TREMERA study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (RA). Recent international treatment recommendations emphasise the need to diagnose RA early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. Remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. Tocilizumab (TCZ) is a newly introduced biologic drug that is used in established RA. The TREMERA study primarily aims to investigate the biological changes seen in blood and tissue following TCZ therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as TCZ can also switch off immunological parameters associated with a disrupted immune system of RA. The study will assess the effectiveness of TCZ given on its own or in combination with methotrexate (MTX; a standard therapy usually given with biologic treatments)in patients with early onset RA to determine the proportion that achieve remission. This study also aims to find out how quickly remission can be achieved with TCZ and the depth of remission achieved. This will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (MRI) which can detect inflammation not apparent on clinical assessment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of rheumatoid arthritis (2010 ACR/EULAR RA classification criteria)
  • Symptom duration ≤12months
  • No previous disease modifying antirheumatic drug (DMARD) therapy
  • Active RA at baseline (defined as: DAS28 ≥ 3.2)
  • Active hand and/or wrist joint evaluable by US and MRI (with no planned surgery during the study period)
  • Patients without any contraindication to MRI

Exclusion criteria

  • Patients unwilling or unable to receive MTX for the duration of the study.
  • Patients with inflammatory joint disease of different origin, mixed connective tissue disease, Reiter's syndrome, psoriatic arthritis, systemic lupus erythematosis, or any arthritis with onset prior to 16 years of age.
  • Suspicion of diagnosis of tuberculosis (TB): positive quantiferon +/abnormal chest x-ray, as per clinician judgement. Prior history of TB with confirmed full chemotherapy +/latent TB adequately treated may be included as per physician's discretion.
  • Intramuscular, oral or intraarticular (of non-target joint) corticosteroid within 28 days of the screening visit; intra-articular steroid of the chosen target joint within 12 weeks of screening.
  • Patients with serious infections within 3 month of enrolment (screening) or persistent infections.
  • Patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ).
  • Known positive serology for hepatitis B or C, or HIV

Treatment and study plan

Tocilizumab

Drug

methotrexate

Drug

Primary outcomes

  1. Evaluate change in expression of JAK 1 and 3 (as well as STAT and p38 MAPK).

    Time frame: To week 60

    Changes up to week 60

Secondary outcomes

  1. Reduction in inflammation in each treatment arm using ultrasound

    Time frame: To week 48

    Establish reduction in inflammation in each treatment arm using ultrasound using grey scale power doppler

  2. Disease Activity Score (DAS): DAS28/44 remission

    Time frame: To week 48

    Proportion of patients achieving DAS28/44 remission

  3. Questionnaires and research tools

    Time frame: Week 48

    Using tools including DAS28/44, SDAI, CDAI

  4. Health Assessment Questionniaire (HAQ) scores

    Time frame: To week 48

    The change from baseline in HAQ scores.

  5. VAS scores questionnaire

    Time frame: To week 48

    The change in VAS scores for pain, disease activity

  6. Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire

    Time frame: To week 48

    The change in RAQoL from baseline

  7. Bone densitometry

    Time frame: Week 48.

    Bone densitometry scan of hands, spine, femoral neck

  8. Sharp score on plain radiographs

    Time frame: Week 48.

    Change in modified Sharp score on plain radiographs

Other outcomes

  1. MRI sub-study (separately consented) - optional

    Time frame: To week 48

    Establish if reduction in RA MRI Scoring system (RAMRIS) synovitis score

  2. Cardiovascular sub-study (separately consented) - optional

    Time frame: To week 48

    Change in cardiovascular measures on cardiac MRI and serum biomarkers

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the Changes in Expression of Janus Kinase/Signal Transducers and Activators of Transcription (JAK-STAT) and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients With Early Rheumatoid Arthritis

Acronym: TREMERA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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