Effect of Monoclonal Anti-IL6 Antibody (Tocilizumab) on the Cardiovascular Risk in Patients With Rheumatoid Arthritis

NCT01752335 | Unknown Phase 4

• 2 other identifiers: FRC-TOC-2009-012010-018658-12
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether tocilizumab changes the cardiovascular risk factors on patients with arthritis rheumatoid. Study hypothesis: the IL-6 contributes to increase the cardiovascular risk factors of patients with rheumatoid arthritis because it produces systemic effects as increasing weight and atherogenic body fat, changing energy homeostasis and inducing the adipokines production and the insulin resistence.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, tocilizumab, cardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

• Framingham Point Scores

  Proportion of changes in Framingham Point Scores

  Baseline and 52 weeks

Secondary Outcomes (5)

• Liver enzymes

  Baseline, 12, 24 and 52 weeks

• Lipoprotein levels

  Baseline, 12, 24 and 52 weeks

• DAS28 score

  Baseline and 52 week

• Number of patients with Adverse Drug Reactions

  up to 52 weeks

• Insulinemia

  Baseline and 52 week

Other Outcomes (2)

• Proportion of brachial artery vasodilation

  Baseline, 24 and 52 weeks

• cytokines, adipokines and adhesion molecules levels

  Baseline and 52 week

Study Arms (1)

tocilizumab

OTHER

All the patients are treated with tocilizumab before inclusion. The doses, frequency and duration are in acordance with the Summary of Characteristics of the Product authorised by EMA. Usually 8mg/kg (not minor than 480 mg), once each 4 weeks.

Other: Braquial ecography

Interventions

Braquial ecography OTHER

At the moment of the ecography, the clinician evaluates the endothelial responses via applying braquial ischemia and administering sublingual nitroglicerin spray to evaluate vasodilation.

tocilizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \<70 years.
• Diagnosis of active Rheumatoid Arthritis, moderate to severe (≥ 3.2 DAS28) of ≥ 6 months duration.
• Patients with an inadequate clinical response to a stable dose of non-biological DMARDs or anti-TNF treatment for a period ≥ 8 weeks before treatment.
• If patients are receiving oral corticosteroids, the dose should have been ≤ 10 mg predinosona and stable for at least one month before the start of treatment (day 1).
• Patients who are able and wish to sign the informed consent and comply with the requirements of the study protocol.

You may not qualify if:

• Major surgery (including joints surgery) within eight weeks prior to the screening visit or major surgery scheduled for six months after first infusion.
• Rheumatoid arthritis with Functional Class IV as defined in the RA Classification of the ACR (complete or significant disability of patients, confined to bed or to the wheelchair and without possibilities to take care themselves).
• Prior or actual inflammatory joint disease different of RA (eg, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease).
• Specific drug criteria
• Treatment with any investigational agent in the four weeks before the screening visit (or time equivalent to five half-lives of the investigational drug, whichever is longer).
• Immunization with a live vaccine / attenuated in the four weeks prior to the baseline visit.
• Pretreatment with TCZ Laboratory Tests (at the screening visit)
• Serum creatinine\> 142 mmol / l (1.6 mg / dL) in women and\> 168 mmol / l (1.9 mg / dl) in men and absence of active renal disease.
• ALT (SGPT) and AST (SGOT)\> 1.5 ULN (if the initial sample of ALT \[SGPT\] or AST \[SGOT\] gives a value\> 1.5 times ULN, you can take and analyze a second sample during the selection period).
• Platelet count \<100 x 109 / l (100.000/mm3).
• Hemoglobin \<85 g / dl (\<8.5 g / l, 5.3 mmol / l).
• Leukocytes \<1.0 x 109 / l (1000/mm3), ANC \<0.5 x 109 / L (500/mm3).
• RAL \<0.5 x 109 / L (500/mm3).
• Positivity for surface antigen of hepatitis B (HBsAg) and antibodies to hepatitis C.
• Total bilirubin\> ULN (if the initial sample of bilirubin\> ULN, you can take and analyze a second sample during the selection period).

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Federico Díaz González, MD, PhD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

ES (1)