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Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA (DOSERA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00858780
First received: March 6, 2009
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Etanercept
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects who are non-failures (still in Period 2) at week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomization to failure, according to predefined criteria. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects in remission or LDA state at each visit. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of time subjects are in remission or LDA state [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in DAS28 at each visit. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in tender and swollen joint counts at each visit. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in physician global assessments, subject global assessments, patient global health VAS, patient pain VAS and morning stiffness at each visit. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in ESR and CRP at each visit. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in mTSS at week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in MRI findings at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Correlation between clinical assessment, serum biomarkers, MRI (at randomization and week 12) and X-ray findings at randomization and whether individuals have had treatment failure or not. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
50mg once weekly + methotrexate
 Drug: Etanercept
50 mg etanercept once weekly + methotrexate
Active Comparator: 2
25mg once weekly + methotrexate
 Drug: Etanercept
25mg etanercept once weekly + methotrexate
Placebo Comparator: 3
once weekly + methotrexate
 Drug: Placebo
Placebo comparator once weekly + methotrexate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria:

  • Subject has a current DAS28 equal to or less than 3.2.
  • Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline
  • Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Exclusion Criteria:

Exclusion criteria:

  • Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state.
  • Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline.
  • Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858780

Locations
Denmark
Pfizer Investigational Site
Glostrup, Denmark, DK-2600
Pfizer Investigational Site
Hellerup, Denmark, 2900
Finland
Pfizer Investigational Site
Helsinki, Finland, FI-00029 HUS
Pfizer Investigational Site
Jyvaskyla, Finland, 40620
Hungary
Pfizer Investigational Site
Gyula, Hungary, 5701
Pfizer Investigational Site
Szombathely, Hungary, 9700
Pfizer Investigational Site
Veszprem, Hungary, 8200
Iceland
Pfizer Investigational Site
Reykjavik, Iceland, 108
Norway
Pfizer Investigational Site
Bergen, Norway, 5021
Pfizer Investigational Site
Lillehammer, Norway, 2609
Pfizer Investigational Site
Oslo, Norway, 0319
Sweden
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Malmo, Sweden, SE-205 02
Pfizer Investigational Site
Stockholm, Sweden, 14186
Pfizer Investigational Site
Stockholm, Sweden, 17176
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00858780     History of Changes
Other Study ID Numbers: 0881K1-4500, B1801016
Study First Received: March 6, 2009
Last Updated: July 11, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Finland: Ethics Committee
Finland: Nat

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on May 23, 2013