Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Methotrexate
Hydroxychloroquine
Sulfasalazine
Hydroxychloroquine sulfate
Methotrexate sodium
Leflunomide
Etanercept
U.S. FDA Resources
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
|
|
Active Comparator: 2
DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
|
Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
|
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
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 Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents 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 May 23, 2013