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A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
MedImmune Ltd
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01050998
First received: January 15, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

To assess the safety, tolerability and efficacy of multiple doses of the drug, CAM-3001 administered in patients with moderately active Rheumatoid Arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CAM3001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The effect of CAM-3001 on the response rate in terms of improvement in DAS28 c-reactive protein (CRP) score on the day of last dose of study drug will be evaluated. [ Time Frame: Study Day 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The assessment of the effects of CAM-3001 on clinical outcomes in RA as measured by ACR20, ACR50 and ACR70, with further assessments of DAS28 response. [ Time Frame: Study Day 85 ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
CAM-3001
Drug: CAM3001

CAM-3001 10 mg SC every other week (total 7 doses)*

*2:1 randomisation CAM-3001:Placebo

Experimental: Cohort 2
CAM-3001
Drug: CAM3001

CAM-3001 30 mg SC every other week (total 7 doses)*

*2:1 randomisation CAM-3001:Placebo

Experimental: Cohort 3
CAM-3001
Drug: CAM3001

CAM-3001 50 mg SC every other week (total 7 doses)*

*2:1 randomisation CAM-3001:Placebo

Experimental: Cohort 4
CAM-3001
Drug: CAM3001

CAM-3001 100 mg SC every other week (total 7 doses)*

*2:1 randomisation CAM-3001:Placebo


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 18 through 80 years (20 to 75 years in Japan) Diagnosis of adult onset Rheumatoid Arthritis of at least 3 months Functional class I-III defined by the 1992 ACR Classification of Functional Status in RA (Hochberg et al, 1992) Treatment with methotrexate at a stable dose

Exclusion Criteria:

A rheumatic autoimmune disease other than RA. Subjects at a high risk of infection Pregnancy Subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050998

  Show 65 Study Locations
Sponsors and Collaborators
MedImmune LLC
MedImmune Ltd
Investigators
Study Director: Gopinath Ranganna, M.D. MedImmune Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01050998     History of Changes
Other Study ID Numbers: MI-CP219
Study First Received: January 15, 2010
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014