|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
9 October 2012 |
|
Main ID: |
EUCTR2005-000158-61-GB |
|
Date of registration:
|
27/05/2005 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
|
|
Scientific title:
|
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -
|
|
Date of first enrolment:
|
18/07/2005 |
|
Target sample size:
|
2210 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000158-61 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Czech Republic
|
Denmark
|
Estonia
|
Germany
|
Hungary
|
Ireland
|
Italy
|
Latvia
|
|
Lithuania
|
Spain
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Subject is a male or female outpatient, at least 18 years of age.
A female is eligible to enter and participate in the study if she is of:
a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); or,
b. Childbearing potential, has a negative pregnancy test and is not lactating at the Screening Visit and Baseline Visit, and agrees to satisfying one of the requirements listed in the protocol : Acceptable Methods of Contraception.
2. Subject is able and willing to give written informed consent.
3. Subject is able to read, comprehend and record information required in the protocol, e.g., complete assessments using an electronic device.
4. Onset of RA at >16 years of age and symptom duration for >12 months.
5. Diagnosis of RA as defined by the American Rheumatism Association (ARA) 1987 criteria.
6. ARA Functional Class I, II or III.
7. Required a NSAID or COX-2 inhibitor for the treatment of their RA for at least 5 out of 7 days of each week for the 4 weeks prior to screen.
8. Satisfies all the following definitions of active disease and baseline criteria defined by:
• a minimum of six tender/painful joints at baseline with an increase of at least two tender/painful joints (or 20% increase, whichever is greater) at baseline compared to screen, plus
• a minimum of three swollen joints at baseline with an increase of at least two swollen joints (or 20% increase, whichever is greater) at baseline compared to screen, plus
• a patient’s assessment of pain (VAS) of at least 40mm at baseline with an increase of at least 10mm (or 20% increase, whichever is greater) at baseline as compared to screen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Listed below are the principal exclusion criteria with numbers corresponding to those used in the protocol. Please refer to protocol for full list of criteria.
5. Active gastrointestinal (GI) ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis).
8. Use of proton pump inhibitors (e.g., omeprazole, lansoprazole) at a dose outside those specified in the label.
11. History of coronary artery disease (angina [stable or unstable], myocardial infarction or any coronary artery surgery). Note myocardial infarction includes history of clinical event or age-indeterminate event on ECG. Subjects with a screening ECG indicating a previous myocardial infarction, as reported by the central ECG reader, are excluded.
12. History of congestive heart failure or renal artery stenosis
13. History of stroke or transient ischemic attack
14. Uncontrolled hypertension (treated or untreated) at screen (sitting systolic blood pressure [SBP] >160mmHg and/or sitting diastolic blood pressure [DBP] >90mmHg).
15. Subjects taking aspirin regularly as an analgesic and are unable to washout 5x’s the half-life prior to base line are excluded; low dose [=325mg per day] for cardiovascular prophylaxis is permitted during the study.
16. Use of a combination of a diuretic with either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Note that subjects taking only a diuretic, or only an ACE/ARB drug, are not excluded. Agents covered by this criteria are listed in (Appendix 6).
17. Use of anticoagulants (warfarin, heparin) or anti-platelet aggregation agents (excluding low-dose aspirin) or a condition associated with decreased haemostasis.
21. Participation in another investigational drug or device study during the 3 months prior to the Baseline/Randomisation Visit, participation in a study of a marketed NSAID or COX-2 inhibitor, given in accordance with the dosage and administration section of the approved product labelling, during the month prior to the Baseline/Randomisation Visit, or will participate simultaneously in another clinical study.
23. Initiation or change of dose of a standard disease modifying anti-rheumatic drug (DMARD) within 12 weeks prior to baseline, e.g., penicillamine, sulfasalazine, oral or intramuscular gold salts, azathioprine, antimalarials and leflunomide (Arava).
24. Use of methotrexate at doses of >20mg/week or initiation or change to the dose of methotrexate within 8 weeks prior to baseline.
25. Use at doses outside those specified in the label of biological anticytokine directed therapeutics (e.g., anti-tumor necrosis factor [TNF]) or given at a dose interval other than the following: at least weekly, every 2 weeks, or every 4 weeks. These agents, at allowed dose intervals, may be used if stable for 6 months prior to baseline.
26. Use of B-cell targeted therapy (e.g., rituximab) if not stable for 6 months prior to Screen or at doses/schedules outside the label. Appropriate monitoring must have been performed.
27. Use of oral corticosteroids at doses greater than the equivalent of 10 mg/day of prednisolone/prednisone (average daily dose for patients on alternating doses) or initiation of treatment within 4 weeks prior to commencing study drug. Corticosteroid doses should remain stable throughout the study.
28. Intra-articular injections within 4 weeks prior to commencing study drug or during the study period (or anti
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Rheumatoid Arthritis
MedDRA version: 7.1
Level: LLT
Classification code 10039073
|
|
Intervention(s)
|
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: GW406381
Product Code: GW406381X
Pharmaceutical Form: Capsule, hard
CAS Number: 221148-46-5
Current Sponsor code: GW406381
Other descriptive name: GW406381X
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Celebrex 200 mg capsule, hard
Product Name: Celecoxib
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Celecoxib
CAS Number: 169590-42-5
Current Sponsor code: Celecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
|
Main Objective: • To evaluate the clinical efficacy of GW406381versus placebo in the treatment of the signs and symptoms of Rheumatoid Arthirtis.
|
Secondary Objective: • To evaluate the safety and tolerability of GW406381 administered orally to subjects with Rheumatoid Arthirtis.
• To evaluate the optimal therapeutic dose(s) of GW406381 for further clinical investigations in rheumatoid arthritis.
• To explore the effect of GW406381 versus celecoxib on pain intensity and function in subject with Rheumatoid Arthirtis.
• To evaluate health outcomes data generated from subject completed questionnaires.
• To evaluate population pharmacokinetics (PK)/pharmacodynamics (PD) of GW406381 in subjects with Rheumatoid Arthirtis.
|
Primary end point(s): • Percentage of American College of Rheumatology (ACR)20 Responders at the end of treatment (Week 12): a clinical response will be defined according to ACR response criteria, i.e., a >20% improvement in 1 and 2 below, coupled with at least a 20% improvement in three of the remaining five parameters.
1. Tender/painful joint count.
2. Swollen joint count.
3. Patient’s pain assessment (Visual Analogue Scale [VAS]).
4. Physician’s global assessment of Rheumatoid Arthritis (VAS).
5. Patient’s global assessment of Rheumatoid Arthritis (VAS).
6. Functional disability index (Health Assessment Questionnaire [HAQ]).
7. C-reactive protein (CRP).
|
|
Source(s) of Monetary Support
|
|
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|