Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents

Pfizer

Status

Terminated

Conditions

Rheumatoid Arthritis (RA)

Treatments

Other: non-interventional study

Study type

Observational

Funder types

Industry

Identifiers

NCT01691014

B1801347

Details and patient eligibility

About

The rationale for this study is to further explore if development of antibodies against TNF-α blocking agents is associated with reduced clinical effect/worsened clinical outcome. An important aspect of the study is to carry out an exploratory analysis of the immunogenicity of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same cell-based assay.

Full description

no sampling

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject fulfils criteria for Rheumatoid Arthritis (RA) according to ACR or EULAR criteria.
Subjects who are planned to start treatment with ADA, ETA, CER or IFX
Subjects taking a minimum weekly dose of 7.5 mg of methotrexate

Exclusion criteria

Patients with compliance problems
Patients who have difficulties in reading and understanding local language
Patients with Juvenile Idiopathic Arthritis (JIA)
Azathioprine or cyclophosphamide treatment within 6 months before entering into the study

Trial design

79 participants in 4 patient groups

adalimumab

Treatment:

Other: non-interventional study

Etanercept

Treatment:

Other: non-interventional study

infliximab

Treatment:

Other: non-interventional study

Certolizumab

Treatment:

Other: non-interventional study

Trial contacts and locations

13

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