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

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01691014
• Other study ID #: B1801347
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2012
• Last updated: March 23, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

no sampling

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Other:
• non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
• non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
• non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
• non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital Nord/Reumatologisk Afdelning	Aalborg
Denmark	Aarhus Universitetshospital/Reumatologisk Afdelning U	Aarhus C.
Denmark	Sydvestjysk Sygehus / Reumatologisk Afdeling	Esbjerg
Denmark	Frederiksberg Hospital / Reumatologisk Afdeling	Frederiksberg
Denmark	Gentofte Hospital, Medicinsk afd. C	Hellerup
Denmark	Hillerod Hospital/Reumatologisk Afdeling	Hillerod
Denmark	Holbaek Sygehus	Holbaek
Denmark	Reumatologisk afd	Kolding
Denmark	Odense Universitets Hospital/Reumatologisk Afdeling C	Odense C
Denmark	Regionshospitalet Randers / Reumatologisk Klinik	Randers NØ
Denmark	Svendborg Sygehus / Medicinsk Afdeling M	Svendborg
Denmark	Vejle Sygehus / Medicinsk Afdeling	Vejle
Denmark	Hospitalsenheden Viborg Reumatologisk Ambulatorium	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-drug antibody levels and serum levels of active drug 6 months after initiation of treatment with adalimumab (ADL), certolizumab (CER), etanercept (ETA) or infliximab (IFX).		6 months	No
Secondary	Description of the association between the formation of antibodies to ADL, CER, ETA and IFX 6 months after initiation of treatment with ADL, CER, ETA or IFX and the clinical response 12 months after initiation of treatment		12 months	No
Secondary	Anti-drug antibody levels 3 and 12 months after initiation of treatment with ADL, CER, ETA or IFX		3 and 12 months	No
Secondary	Description of the association between the formation of anti-drug antibodies and concomitant methotrexate (MTX)		12 months	No
Secondary	DAS 28 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX.		3, 6 and 12 months	No
Secondary	HAQ score at baseline, 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX.		3, 6 and 12 months	No

External Links

•   To obtain contact information for a study center near you, click here.