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

NCT01691014 | Terminated Results

• 1 other identifier: B1801347
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab

  Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.

  Month 6

• Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab

  Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.

  Month 6

Secondary Outcomes (7)

• Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment

  Month 6, 12

• Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment

  Month 6, 12

• Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits

  Month 6, 12

• Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab

  Month 3, 12

• Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment

  Month 12

Study Arms (4)

adalimumab

Other: non-interventional study

Etanercept

Other: non-interventional study

infliximab

Other: non-interventional study

Certolizumab

Other: non-interventional study

Interventions

non-interventional study OTHER

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

adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Rheumatoid Arthritis (RA)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Aalborg Universitetshospital Nord/Reumatologisk Afdelning

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital/Reumatologisk Afdelning U

Aarhus C, 8000, Denmark

Location

Sydvestjysk Sygehus / Reumatologisk Afdeling

Esbjerg, 6700, Denmark

Location

Frederiksberg Hospital / Reumatologisk Afdeling

Frederiksberg, 2000, Denmark

Location

Gentofte Hospital, Medicinsk afd. C

Hellerup, 2900, Denmark

Location

Hillerod Hospital/Reumatologisk Afdeling

Hillerød, 3400, Denmark

Location

Holbaek Sygehus

Holbæk, 4300, Denmark

Location

Reumatologisk afd

Kolding, 6000, Denmark

Location

Odense Universitets Hospital/Reumatologisk Afdeling C

Odense C, 5000, Denmark

Location

Regionshospitalet Randers / Reumatologisk Klinik

Randers NØ, 8930, Denmark

Location

Svendborg Sygehus / Medicinsk Afdeling M

Svendborg, 5700, Denmark

Location

Vejle Sygehus / Medicinsk Afdeling

Vejle, 7100, Denmark

Location

Hospitalsenheden Viborg Reumatologisk Ambulatorium

Viborg, 8800, Denmark

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.

Results Point of Contact

• Title: Pfizer Inc.
• Organization: Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

001 800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-11

Locations

DK (13)