Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

NCT00706797 | Terminated Phase 4 Results

• 1 other identifier: 0881X1-4437
• Study Type: interventional
• Target: 141
• Locations: 9 countries
• Sites: 45

Brief Summary

To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

Conditions

Rheumatoid Arthritis

Keywords

Moderate Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Total Sharp Score (TSS) at Week 52

  Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 \[no narrowing\] to 168 \[high narrowing\]) plus (+) erosion score (range is from 0 \[no erosion\] to 280 \[high erosion\]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

  Baseline, Week 52

Secondary Outcomes (17)

• Change From Baseline in Erosions at Week 52

  Baseline, Week 52

• Change From Baseline in Joint Space Narrowing at Week 52

  Baseline, Week 52

• Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52

  Baseline, Week 52, Last observation carried forward (LOCF)

• Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)

  Baseline, Week 12, Week 24, and Week 52

• Percentage of Participants Achieving Remission (DAS28 <2.60)

  Week 12, Week 24, and Week 52

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).

Drug: methotrexate

ETN + MTX

ACTIVE COMPARATOR

Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).

Drug: etanercept (EnbrelTM); Drug: methotrexate

Interventions

etanercept (EnbrelTM) DRUG

ETN + MTX

methotrexate DRUG

ETN + MTX; Usual care

Eligibility Criteria

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

You may qualify if:

• Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
• Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
• Have received MTX as stable dose for 28 days prior to the screening visit.

You may not qualify if:

• Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
• Receipt of any DMARD, other than MTX, within 28 days before screening.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (45)

Unknown Facility

Ostrava, 722 00, Czechia

Location

Unknown Facility

Prague, 128-50, Czechia

Location

Unknown Facility

Prague, 140-59, Czechia

Location

Unknown Facility

Amiens, 80054, France

Location

Unknown Facility

Échirolles, 38130, France

Location

Unknown Facility

Metz, 57077, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Paris, 75679, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Cologne, 50924, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Hamburg-Eilbeck, 22081, Germany

Location

Unknown Facility

Homburg, 66424, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

Unknown Facility

Budapest, 1023, Hungary

Location

Unknown Facility

Budapest, 1036, Hungary

Location

Unknown Facility

Miskolc, 3529, Hungary

Location

Unknown Facility

Rijeka, 51000, Hungary

Location

Unknown Facility

Split, 21000, Hungary

Location

Unknown Facility

Zagreb, 10000, Hungary

Location

Unknown Facility

Jesi (Ancona), 60035, Italy

Location

Unknown Facility

Reggio Calabria, 89100, Italy

Location

Unknown Facility

Bytom, 41-902, Poland

Location

Unknown Facility

Krakow, 31-531, Poland

Location

Unknown Facility

Ustroń, 43-450, Poland

Location

Unknown Facility

Warsaw, 00-909, Poland

Location

Unknown Facility

Warsaw, 02-637, Poland

Location

Unknown Facility

Wroclaw, 50-088, Poland

Location

Unknown Facility

Santander, Cantabria, 39008, Spain

Location

Unknown Facility

Getafe, Madrid, 28902, Spain

Location

Unknown Facility

Madrid, Madrid, 28006, Spain

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

Unknown Facility

Bilbao, Vizcaya, 48013, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Valencia, 46010, Spain

Location

Unknown Facility

Izmir, 35340, Turkey (Türkiye)

Location

Unknown Facility

Cambridge, Cambs, CB2 2QQ, United Kingdom

Location

Unknown Facility

Birmingham, West Midlands, WS11 5XY, United Kingdom

Location

Unknown Facility

Aintree, L9 7AL, United Kingdom

Location

Unknown Facility

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

Unknown Facility

Newcastle, NE7 7DN, United Kingdom

Location

Related Publications (2)

• Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.

  PMID: 23213004 DERIVED

• Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.

  PMID: 22131049 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Following early termination of the study, only disposition of randomized participants, description of demographic data on safety population, and safety analyses were performed.

Results Point of Contact

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

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 30, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 21, 2011
• Results First Posted: January 10, 2011

Record last verified: 2011-06

Locations

PL (6); TU (1); ES (8); CZ (3); IT (2); FR (8); DE (6); HU (6); GB (5)