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A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.

This study has been completed.
Sponsor:
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00141934
First received: August 31, 2005
Last updated: April 4, 2007
Last verified: April 2007

August 31, 2005
April 4, 2007
August 2005
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Complete list of historical versions of study NCT00141934 on ClinicalTrials.gov Archive Site
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A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.

AD 452 is a new drug which is being developed for use in adult patients with RA. It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3 month study. Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study. An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics, safety and tolerability of AD 452 taken for one month. The drug was well tolerated and no significant drug related adverse events were reported.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: AD 452
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
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Inclusion Criteria:

  • Male/female age 18 -75
  • RA diagnosed for at least 6 months
  • Taking methotrexate for at least 6 months
  • Must have at least 4 swollen/tender joints

Exclusion Criteria:

  • Must not be pregnant/breastfeeding
  • Must not have history of other inflammatory disorders
  • Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, HIV, active infection, hepatitis B/C, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141934
P-AD452-022
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Sosei
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Sosei
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP