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

NCT ID: NCT01691014

Last Updated: 2016-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

Brief Summary

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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

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no sampling

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adalimumab

non-interventional study

Intervention Type OTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Etanercept

non-interventional study

Intervention Type OTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

infliximab

non-interventional study

Intervention Type OTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Certolizumab

non-interventional study

Intervention Type OTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Interventions

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non-interventional study

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Intervention Type OTHER

non-interventional study

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Intervention Type OTHER

non-interventional study

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Intervention Type OTHER

non-interventional study

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Aalborg Universitetshospital Nord/Reumatologisk Afdelning

Aalborg, , Denmark

Site Status

Aarhus Universitetshospital/Reumatologisk Afdelning U

Aarhus C, , Denmark

Site Status

Sydvestjysk Sygehus / Reumatologisk Afdeling

Esbjerg, , Denmark

Site Status

Frederiksberg Hospital / Reumatologisk Afdeling

Frederiksberg, , Denmark

Site Status

Gentofte Hospital, Medicinsk afd. C

Hellerup, , Denmark

Site Status

Hillerod Hospital/Reumatologisk Afdeling

Hillerød, , Denmark

Site Status

Holbaek Sygehus

Holbæk, , Denmark

Site Status

Reumatologisk afd

Kolding, , Denmark

Site Status

Odense Universitets Hospital/Reumatologisk Afdeling C

Odense C, , Denmark

Site Status

Regionshospitalet Randers / Reumatologisk Klinik

Randers NØ, , Denmark

Site Status

Svendborg Sygehus / Medicinsk Afdeling M

Svendborg, , Denmark

Site Status

Vejle Sygehus / Medicinsk Afdeling

Vejle, , Denmark

Site Status

Hospitalsenheden Viborg Reumatologisk Ambulatorium

Viborg, , Denmark

Site Status

Countries

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Denmark

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801347&StudyName=Formation%20of%20Antibodies%20and%20Subsequent%20Prediction%20of%20Clinical%20Response%20in%20Patients%20with%20Rheumatoid%20Arthritis%20Treated%20with%20four%20TNF%20Blockin

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Other Identifiers

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B1801347

Identifier Type: -

Identifier Source: org_study_id