Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00422227
First received: January 11, 2007
Last updated: July 28, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept , Methotrexate
Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening.

    The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.



Secondary Outcome Measures:
  • Percentage of Participants Achieving ACR 20, 50, and 70 Responses [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Response includes improvement in tender or swollen joints as well as 20 percent improvement in three of the other five criteria. Required: ≥ 20%, 50% or 70% improvement in tender joint count ≥ 20% , 50% or 70% improvement in swollen joint count and at least 20%, 50%, 70% improvement in 3 of the following 5:Patient pain assessment , Patient global assessment ,Physician global assessment, Patient self-assessed disability.

  • Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).

  • Percent Change From Baseline in DAS28 at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR)) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).

  • Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    EULAR Response Criteria DAS28) improvement at week 16. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.

  • Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Disease Activity Score 28 based on 28 Joints (DAS28) is the calculation of DAS28: DAS28 = 0.56 sqrt (28 painful joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln erythrocyte sedimentation rate (ESR) + 0.014 (General Health) (GH). GH = Subject general health visual analog scale (0-10 mm).

  • Percent Change From Baseline in Painful and Swollen Joint Counts [ Time Frame: Week 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
    Participant's assessment of pain - A horizontal pain visual analog scale (VAS) (0-100 mm) is used to assess the participants current level of pain; 0 = no pain and 100 = worst pain. Swollen joint count - ACR swollen joint count, an assessment of 28 joints. Joints are classified as either swollen or not swollen.

  • Percent Change From Baseline in Physician And Subject Global Assessments [ Time Frame: Week 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
    The Physician Global Assessment of Disease Activity: The participant's disease activity is estimated over the last two - three days by the physician; A zero (0) means no disease activity and a ten (10) means extreme disease activity. The Subject Global Assessment of Disease Activity: The participant assesses overall arthritis activity. A zero (0) means no disease activity and a ten (10) means extreme disease activity.

  • Percent Change From Baseline in Duration (Minutes) of Morning Stiffness [ Time Frame: Week 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
    The duration of morning stiffness on the day of examination should be determined by asking the following two questions: When did you awaken this morning? When were you able to resume your normal activities without stiffness? Duration of morning stiffness is equal to the time elapsed between the above two times in minutes; If none is present enter 0, If morning stiffness is still continuing, please indicate average of duration of stiffness over the past 3 days. If stiffness persists the entire day 1440 minutes (24h x 60 minutes) should be recorded.

  • Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales [ Time Frame: Week 2, 4, 8, 12, 16 ] [ Designated as safety issue: No ]
    VAS, participant indicates by marking a vertical line at an appropriate position through a horizontal line. The length of the line measures from left (in mm) and the value (in mm) is recorded. General Health VAS, "in general how would you rate your heath over the last 2-3 weeks", 0mm equals very well and 100mm equals extremely bad. Pain VAS: "indicate the amount of pain experienced during the last 2-3 days", 0 mm equals no pain and 100 mm equals pain as bad as it can be. Fatigue VAS: "how fatigued or tired have you been over the last week", range =No Fatigue - Extremely Fatigued.


Enrollment: 300
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Etanercept + Methotrexate
Drug: Etanercept , Methotrexate
  • Etanercept: 25 mg twice weekly over 16 weeks, SC
  • Methotrexate: > 7.5 mg/week and no more than 25 mg/week, PO
Active Comparator: 2
DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
  • Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO
  • Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO
  • Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day
  • Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of RA
  • Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
  • Active RA at time of screening and baseline

Exclusion Criteria:

  • Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a DMARD, other than MTX, at screening
  • Receipt of any DMARD, other than MTX, within 3 months before screening
  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: NCT00422227

Locations
Hong Kong
Hong Kong, Hong Kong
India
Bangalore, India, 560017
Bangalore, India, 560034
Hyderabaad, India, 500082
New Delhi, India, 110029
Korea, Republic of
In Cheon, Korea, Korea, Republic of, 400-711
Seoul, Korea, Korea, Republic of, 138-736
Seoul, Korea, Korea, Republic of, 120-752
Seoul, Korea, Korea, Republic of, 110-744
Seoul, Korea, Korea, Republic of, 133-792
Seoul, Korea, Korea, Republic of, 137-701
Malaysia
Ipoh, Perak, Malaysia, 30450
Kuala Lumpur, Malaysia, 68100
Pulau Pinang, Malaysia, 10450
Putrajaya, Malaysia, 62250
Seremban, Malaysia, 70300
Philippines
Cebu, Philippines, 6000
Makati City, Philippines, 1200
Manila, Philippines, 1004
Manila, Philippines, 1000
Manila, Philippines, 1500
Quezon City, Philippines, 1102
Singapore
Singapore, Singapore, 308433
Taiwan
Kaohsiung City, Taiwan, 807
Taipei, Taiwan, 112
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10400
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Hong Kong: medinfo@wyeth.com
Principal Investigator: Trial Manager For Taiwan: medinfo@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00422227     History of Changes
Other Study ID Numbers: 0881A1-408
Study First Received: January 11, 2007
Results First Received: March 31, 2010
Last Updated: July 28, 2010
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Methotrexate
Leflunomide
TNFR-Fc fusion protein
Sulfasalazine
Antirheumatic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 15, 2014