Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Amgen
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00848354
First received: February 18, 2009
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Phase 1: Etanercept Drug: Phase 1: Methotrexate Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX Drug: Phase 1: Conventiaonal DMARD |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Open-Label Study In the Latin America Region Comparing the Safety And Efficacy Of Etanercept With Conventional DMARD Therapy In Subjects With Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants Achieving American College of Rheumatology 50 (ACR 50) Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]ACR50 response: greater than or equal to 50 percent improvement from baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Secondary Outcome Measures:
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]SF-36: 36-item questionnaire that measures general health-related quality of life in the following eight domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0-100 where higher scores are better (100=highest level of functioning) and may be reported as 2 summary scores; Mental Component Score and Physical Component Score. Total score range for the summary scores = 0-100 where higher scores are better.
- Van Der Heijde Modified Total Sharp Score (vdH mTSS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]mTSS = sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
- Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
- Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 52 and 104 of Phase 2 [ Time Frame: Baseline, Week 52 and 104 of Phase 2 ] [ Designated as safety issue: No ]DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
- Therapeutic Change Observed at Start of Phase 2 [ Time Frame: Week 52 of Phase 2 ] [ Designated as safety issue: No ]Therapeutic change observed at start of Phase 2 described the changes made by investigator to participant treatment based on efficacy of Phase 1 randomized therapy.
| Enrollment: | 429 |
| Study Start Date: | May 2009 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase 1 Etanercept + methotrexate
Phase 1: Etanercept + methotrexate
|
Biological: Phase 1: Etanercept
Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
Other Name: Enbrel
Drug: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX
Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128. |
|
Active Comparator: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
|
Drug: Phase 1: Methotrexate
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Drug: Phase 1: Conventiaonal DMARD
Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
|
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis (RA)
- Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
- Active Rheumatoid Arthritis (RA) at time of screening and baseline
Exclusion Criteria:
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
- Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
- Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848354
Locations
| Argentina | |
| Pfizer Investigational Site | |
| Capital Federal, Buenos Aires, Argentina, C1425EKF | |
| Pfizer Investigational Site | |
| San Juan, Provinica de San Juan, Argentina, 5400 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1055 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1280 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1015 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1426 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1114 | |
| Pfizer Investigational Site | |
| Ciudad de Buenos Aires, Argentina, C1128AAF | |
| Pfizer Investigational Site | |
| Cordoba, Argentina, 5000 | |
| Pfizer Investigational Site | |
| Corrientes, Argentina, 3400 | |
| Pfizer Investigational Site | |
| San Miguel de Tucuman, Argentina, 4000 | |
| Pfizer Investigational Site | |
| Santa Fe, Argentina, 2200 | |
| Pfizer Investigational Site | |
| Tucuman, Argentina, 4000 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, Region Metropolitana, Chile | |
| Colombia | |
| Pfizer Investigational Site | |
| Medellin, Antioquia, Colombia | |
| Pfizer Investigational Site | |
| Barranquilla, Atlantico, Colombia, 0000 | |
| Pfizer Investigational Site | |
| Barranquilla, Atlantico, Colombia | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia, 0000 | |
| Pfizer Investigational Site | |
| Bogota, Cundinamarca, Colombia | |
| Pfizer Investigational Site | |
| Chia, Cundinamarca, Colombia | |
| Pfizer Investigational Site | |
| Bucaramanga, Santander, Colombia | |
| Mexico | |
| Pfizer Investigational Site | |
| Guadajara, Jalisco, Mexico, 45040 | |
| Pfizer Investigational Site | |
| Merida, Yucatan, Mexico | |
| Pfizer Investigational Site | |
| Chihuahua, Mexico, 31000 | |
| Panama | |
| Pfizer Investigational Site | |
| Panama, Panama | |
Sponsors and Collaborators
Pfizer
Amgen
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00848354 History of Changes |
| Other Study ID Numbers: | 0881A1-4532, B1801004 |
| Study First Received: | February 18, 2009 |
| Results First Received: | February 2, 2012 |
| Last Updated: | May 8, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Pfizer:
|
enbrel moderate arthritis severe arthritis rheumatoid arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Antirheumatic Agents Methotrexate Therapeutic Uses Pharmacologic Actions Abortifacient Agents, Nonsteroidal Abortifacient Agents |
Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
ClinicalTrials.gov processed this record on June 18, 2013