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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01691014
First received: September 12, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis (RA)
Other: non-interventional study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FORMATION OF ANTIBODIES AND SUBSEQUENT PREDICTION OF CLINICAL RESPONSE IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH FOUR TNF BLOCKING AGENTS

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anti-drug antibody levels 3 and 12 months after initiation of treatment with ADL, CER, ETA or IFX [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Description of the association between the formation of anti-drug antibodies and concomitant methotrexate (MTX) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • DAS 28 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • HAQ score at baseline, 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adalimumab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Etanercept Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
infliximab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Certolizumab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Detailed Description:

no sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with Rheumatoid Arthritis (RA)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691014

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Denmark
Aalborg Universitetshospital Nord/Reumatologisk Afdelning Recruiting
Aalborg, Denmark, 9000
Aarhus Universitetshospital/Reumatologisk Afdelning U Recruiting
Aarhus C., Denmark, 8000
Sydvestjysk Sygehus / Reumatologisk Afdeling Recruiting
Esbjerg, Denmark, 6700
Frederiksberg Hospital / Reumatologisk Afdeling Recruiting
Frederiksberg, Denmark, 2000
Gentofte Hospital, Medicinsk afd. C Recruiting
Hellerup, Denmark, 2900
Hillerod Hospital/Reumatologisk Afdeling Recruiting
Hillerod, Denmark, 3400
Holbaek Sygehus Recruiting
Holbaek, Denmark, 4300
Reumatologisk afd Recruiting
Kolding, Denmark, 6000
Odense Universitets Hospital/Reumatologisk Afdeling C Recruiting
Odense C, Denmark, 5000
Regionshospitalet Randers / Reumatologisk Klinik Recruiting
Randers NØ, Denmark, 8930
Svendborg Sygehus / Medicinsk Afdeling M Recruiting
Svendborg, Denmark, 5700
Vejle Sygehus / Medicinsk Afdeling Recruiting
Vejle, Denmark, 7100
Hospitalsenheden Viborg Reumatologisk Ambulatorium Recruiting
Viborg, Denmark, 8800
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01691014     History of Changes
Other Study ID Numbers: B1801347
Study First Received: September 12, 2012
Last Updated: September 10, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014