NCT01691014

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

Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

no sampling

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
OTHER	non-interventional study	Study with 4 arms/groups with 36 patients per group. In total 144 patients.
OTHER	non-interventional study	Study with 4 arms/groups with 36 patients per group. In total 144 patients.
OTHER	non-interventional study	Study with 4 arms/groups with 36 patients per group. In total 144 patients.
OTHER	non-interventional study	Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2012-09-24
• Last updated: 2016-12-29
• Results posted: 2016-12-29

Locations

13 sites across 1 country: Denmark