E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002556 |
E.1.2 | Term | Ankylosing spondylitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The Primary objective of this study is to investigate the efficacy, safety and pharmacokinetics of adalimumab subcutaneous administration every other week in Japanese patients with active ankylosing spondylitis (AS). |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to confirm the similarity of data from this study to data from Study M03-607 and Study M03-606 in European and American
patients with active AS. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs |
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E.4 | Principal exclusion criteria |
•History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
•Previously received anti-TNF therapy
•Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Number of Subjects Achieving ASAS 20
-Number of Subjects Achieving ASAS 50
-Number of Subjects Achieving ASAS 70
-Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)
-Mean Change From Baseline in Patient's Global Assessment of Disease Activity
-Mean Change From Baseline in Total Back Pain
-Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
-Mean Change From Baseline in C-Reactive Protein (CRP)
-Number of Subjects Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6
-Number of Subjects Achieving Assessment in Ankylosing Spondylitis 40 (ASAS 40)
-Number of Subjects Achieving Assessment in Ankylosing Spondylitis Partial Remission
-Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
-Mean Change From Baseline in Chest Expansion
-Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
-Mean Change From Baseline in Nocturnal Pain
-Mean Change From Baseline in Swollen Joint Count for 44 Joints (SJC 44)
-Mean Change From Baseline in Tender Joint Count for 46 Joints (TJC 46)
-Mean Change From Baseline in 36-Item Short Form (SF-36) Questionnaire |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
•ASAS 50 [ Time Frame: Week 12 ]
•ASAS 70 [ Time Frame: Week 12 ]
•Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) [ Time Frame: Week 12 ]
•Evaluation of adverse event, vital sign and laboratory tests [ Time Frame: During study period ] |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |