Response to biologics in rheumatoid arthritis

Response to biologics in rheumatoid arthriits to determine the relationship between antidrug antibodies, drug concentrations and disease activity.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12613000123741

Acronym

NIL

Enrollment

Registered

2013-02-01

Start date

2013-04-08

Completion date

2014-08-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rheumatoid arthritis (RA) is a common condition affecting 1-2% of the population. Early intensive treatment that effectively suppresses the disease is required to prevent irreversible joint damage. Many patients require the newer expensive biologic therapies, access to which is determined by PHARMAC rules. However it is not possible to predict which patients will respond to treatment. Furthermore, patients receive the same dose regimen, which does not allow for differences between patients in how the drug is cleared from the body. Measuring concentrations of drug in the blood may allow better patient outcomes by adjusting the dose regimen. Furthermore, some patients receiving biological therapies may develop antibodies against the drug. The effect of these antibodies on blood concentrations of the drug, or response to the drug or subsequent treatments, is not well established. This study aims to address these issues by measuring drug concentrations and anti-drug antibodies and relating these to treatment effectiveness.

Interventions

This is an observational study. Disease activity will be observed before and 6 months after starting biological therapy. The biological therapy used will be determined by the treating physician on a case by case basis. There will be one observation immediately prior to starting biological therapy. Duration of therapy will be determined by the treating physician depending on response, tolerability and adverse effects

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

I.Male or female, aged >/=18 years, with Rheumatoid Arthritis as defined by the ACR Criteria (Aletaha et al. 2010) receiving or commencing any biologic therapy. II.Able and willing to give written informed consent and to comply with the requirements of the study.

Exclusion criteria

patients with serious uncontrolled chronic concomitant disease

Outcome results