Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT02765074
• Date of registration: 19/04/2016
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Régional d'Orléans
• Public title: Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis REPAIR
• Scientific title: Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study
• Date of first enrolment: June 30, 2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02765074
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: MAROTTE Hubert, MD, PhD
• Affiliation: HOPITAL NORD SAINT ETIENNE

• Name: CANTAGREL Alain, MD, PhD
• Affiliation: CHU Toulouse

• Name: SALLIOT Carine, MD
• Affiliation: CHR ORLEANS

• Name: CHAPURLAT Roland, MD, PhD
• Affiliation: CHU LYON

• Name: Adeline RUYSSEN-WITRAND, Dr

• Name: SALLIOT Carine, MD

• Name: LESPESSAILLES Eric, MD, PhD
• Affiliation: CHR ORLEANS

Key inclusion & exclusion criteria

Inclusion Criteria:

- Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010
classification criteria

- DAS 28 superior or equal to 3.2 despite DMARD or biological treatment (other than
tocilizumab)

- Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays

- Oral corticosteroid = 10 mg/day prednisone or equivalent stable for at least one month

- RA patients eligible to subcutaneous Tocilizumab monotherapy

Exclusion Criteria:

- Treatment with zoledronic acid or denosumab (less than one year)

- Intra-articular injection of corticosteroids at the MCP in the previous three
months

- Tocilizumab contra-indications in accordance with SPC (Summary of Product
Characteristics) :Hypersensitivity to the active substance or to any of the
excipients Active, severe infections including active tuberculosis Diverticulitis
Active hepatic disease and hepatic Impairment including viral hepatitis Elevated
Alanine Aminotransferase or Aspartate Aminotransferase >5×ULN Absolute neutrophil
count < 0.5 × 10 exp 9 /L Platelet count < 50×10 exp 3 /µL,

General:

- Absence of informed consent

- Prior or planned joint surgery of the hands which might impact the interpretation of
imaging assessments.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: subcutaneous tocilizumab

Primary Outcome(s)

Bone erosion change after 12 months of subcutaneous tocilizumab [Time Frame: baseline and 12 months]

Secondary Outcome(s)

Effect of 12 months of tocilizumab on bone microarchitecture in the PR [Time Frame: baseline, 12 months]

Effect of 12 months of tocilizumab on bone density in the PR [Time Frame: baseline, 12 months]

Effect of Tocilizumab on synovitis/tenosynovitis assessed by US and agreement with disease activity scores [Time Frame: Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months]

Associated factors with erosion changes assessed by HRqQCT [Time Frame: baseline, 3 months, 12 months]

Secondary ID(s)

CHRO 2014-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rennes University Hospital