Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Array BioPharma |
---|---|
Information provided by: | Array BioPharma |
ClinicalTrials.gov Identifier: | NCT00811499 |
The purpose of this study is to test the safety and efficacy of ARRY-371797 in patients with ankylosing spondylitis that have not responded to conventional therapy.
Condition | Intervention | Phase |
---|---|---|
Ankylosing Spondylitis |
Drug: ARRY-371797 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of 12 Weeks of Treatment With ARRY-371797 in Patients With Active Ankylosing Spondylitis and Inadequate Response to Conventional Therapy |
Estimated Enrollment: | 168 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
100 mg q12h of ARRY-371797
|
Drug: ARRY-371797
Drug in Capsule
|
2: Experimental
200 mg q12h of ARRY-371797
|
Drug: ARRY-371797
Drug in Capsule
|
3: Experimental
400 mg q24h of ARRY-371797
|
Drug: ARRY-371797
Drug in Capsule
|
4: Placebo Comparator
Placebo
|
Drug: Placebo
Lactose monohydrate in capsule
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has completed a 4-week washout period (calculated from first dose of Study Drug), if treated with any of the following therapies:
Patients may continue on stable background therapy for AS (doses should be stable for at least 4 weeks prior to the first dose of Study Drug) only if it is included in the following list:
If female participant, has met either criterion "a" or "b" below:
Is of non-childbearing potential (amenorrheic for at least 2 years, or had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening);
• All other female patients (including those with tubal ligation) will be considered of childbearing potential.
Exclusion Criteria:
History of:
Presenting with any of the following:
Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments at Screening:
United States, Nebraska | |
Westroads Medical Group | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Tonya Neil 402-934-1666 research@wmgmed.com | |
Principal Investigator: William Palmer, MD | |
United States, Washington | |
Arthritis Northwest | Recruiting |
Spokane, Washington, United States, 99204 | |
Contact: Gretchen Mladjan 509-838-6500 gmladjan@arthritisnw.com | |
Principal Investigator: Gary Craig, MD |
Responsible Party: | Array BioPharma ( Cynthia Schechter ) |
Study ID Numbers: | ARRAY-797-201 |
Study First Received: | December 17, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00811499 |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Spondylarthropathy Arthritis Joint Diseases Spondylitis, Ankylosing |
Spondylarthritis Bone Diseases Spondylitis Ankylosis Spondylarthropathies |
Infection Bone Diseases, Infectious |