Filling bone erosions: a longitudinal multicentric HR-pQCT study of subcutaneous tocilizumab in rheumatoid arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire D Orleans

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

30 Jun 2016 → ongoing

Decision date (initial)

2025-01-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517686-17-01

EudraCT number

2015-004801-18

ClinicalTrials.gov

NCT02765074

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Evaluate the variation in the diameter, depth and volume of erosions measured by HRpQCT in patients with rheumatoid arthritis treated with tocilizumab for 12 months.

Secondary objectives 4

1. Evaluate the effect of subcutaneous tocilizumab on erosions in rheumatoid arthritis
2. Evaluate the effect of subcutaneous tocilizumab on bone metabolism in rheumatoid arthritis
3. Evaluate the effect of subcutaneous tocilizumab on clinical activity in rheumatoid arthritis
4. Evaluate the effect of subcutaneous tocilizumab on ultrasound activity in rheumatoid arthritis

Conditions and MedDRA coding

rheumatoid arthritis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Active RA, < 10 years disease duration, diagnosed according to the ACR-EULAR 2010 classification criteria
2. DAS 28 greater than 3.2 despite DMARD or biological treatment (other than tocilizumab)
3. Superior or equal to one joint erosion at the right or left MCP 2, 3 on X-rays
4. Oral corticosteroid ≤ 10 mg/day prednisone or equivalent stable for at least one month
5. Rhumatoid Arthritis patients eligible to subcutaneous Tocilizumab monotherapy in combination with a DMARD or as monotherapy (according to MA)
6. Men and women at least 18 years old

Exclusion criteria 6

1. Treatment with zoledronic acid or denosumab (less than one year)
2. Intra-articular injection of corticosteroids at the MCP in the previous three months
3. Patients with confluent erosions on ultrasonography
4. 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,
5. Absence of informed consent
6. Prior or planned joint surgery of the hands which might impact the interpretation of imaging assessments

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Bone erosion change of width, depth and volume measured by HRpQCT after 12 months of subcutaneous tocilizumab

Secondary endpoints 4

1. Number of participants with associated factors with erosion changes by HRpQCT (Associated therapeutic, clinical and biological response )ultrasound ...)
2. Changes of Bone mineral density by DXA at the lumbar spine and proximal femur
3. Correlation Between clinical activity measured by various indices (Disease Activity Score 28, Clinical Disease Activity Iindex , Simplify Disease Activity Index , American College of Rheumatology - European League against Rheumatism: ACR EULAR) and ultrasound data.
4. Changes of bone microarchitecture by tibia HRpQCT

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire D Orleans

Sponsor organisation

Centre Hospitalier Universitaire D Orleans

Address

14 Avenue De L Hopital, Cs 86709 Cs 86709

City

Orleans Cedex 2

Postcode

45067

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire D Orleans

Contact name

Clinical Trial Coordinator

Public contact point

Organisation

Centre Hospitalier Universitaire D Orleans

Contact name

Clinical Project manager

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications