A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC ( MedImmune Ltd )
ClinicalTrials.gov Identifier:
NCT00771420
First received: October 10, 2008
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CAM-3001
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis.

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group: [ Time Frame: Day 28 post infusion ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
0.01mg/kg and 0.03mg/kg CAM-3001
Drug: CAM-3001
A single patient shall be dosed with a dose of 0.01mg/kg of CAM-3001 followed no sooner than 24 hours later by a second patient at a dose of 0.03mg/kg.
Other Name: Mavrilimumab
Active Comparator: 2
0.1mg/kg CAM-3001
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Name: Mavrilimumab
Active Comparator: 3
0.3mg/kg CAM-3001
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Name: Mavrilimumab
Active Comparator: 4
1.0mg/kg CAM-3001
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Name: Mavrilimumab
Active Comparator: 5
3.0mg/kgCAM-3001
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Name: Mavriliumab
Active Comparator: 6
10.0mg/kg CAM-3001
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Name: Mavrilimumab
Placebo Comparator: 7
Placebo
Other: Placebo
Active: Placebo 5:1 for arms 2-6
Other Name: Placebo

Detailed Description:

To investigate the safety and tolerability of escalating single doses of CAM-3001 in patients with RA; To investigate the pharmacokinetics of single doses of CAM-3001 in RA patients; To investigate the pharmacodynamics of single doses of CAM-3001 in RA patients; To investigate the preliminary clinical effects of CAM-3001 on the signs and symptoms of RA.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent, prior to any study related procedures
  • Male and female patients aged 18-70 years at the screening visit
  • Use of an appropriate method of contraception
  • A diagnosis of adult onset rheumatoid arthritis of at least 6 months duration as defined by the 1987 ACR classification criteria - ACR functional class I, II or III
  • Treatment with methotrexate for at least 3 months and stable dose 10mg - 25mg / week for ≥ 8 weeks prior to the baseline visit
  • Availability of clear chest X-ray (i.e. no evidence of TB, chest infection or cardiac failure). Patients who are clinically asymptomatic with minor changes consistent with rheumatoid lung are acceptable.
  • Stable mild or inactive rheumatoid arthritis where in the opinion of the investigator it is unlikely that a change in the patient's therapeutic regimen would be required during the subsequent 3 months.
  • DAS28 ≤ 4.8 for at least 3 months prior to the baseline visit

Exclusion Criteria:

  • Relating to RA
  • Diagnosis of any other inflammatory arthritis (e.g. psoriatic arthritis or ankylosing spondylitis), or a diagnosis of a secondary, non-inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with the evaluation of the effect of CAM-3001 on the patient's primary diagnosis of rheumatoid arthritis Relating to Previous Clinical Trials and Biologic Therapies
  • Administration of any investigational or experimental non-biologic therapy in the 12 weeks prior to the baseline visit
  • Administration of any biologic therapy within 6 months prior to the baseline visit Relating to Concomitant Medications
  • Use of prohibited concomitant medications, which might confound the interpretation of the study data Relating to Medical History
  • Female patients who are pregnant or breast-feeding, or who plan to become pregnant during the trial or during the 24 weeks after administration of CAM-3001
  • Male or female patients not willing to use reliable methods of birth control for the duration of the study
  • A history of TB, or clinical/radiographic evidence of TB, or positive TB test
  • A history or current symptoms and signs of chronic infection, or recent (within 6 months prior to screening visit) serious infection including herpes zoster
  • Patients at a high risk of infection e.g. a history of an infected joint prosthesis at any time with that prosthesis still in situ, leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections
  • Neutrophil count < 1000 x 106 cells/L
  • A positive hepatitis B surface antigen test and/or hepatitis C antibody test result
  • A positive test for human immunodeficiency virus (HIV) infection
  • Receipt of live (attenuated) vaccine within the 4 weeks prior to baseline or during the study
  • Current or recent history of significant renal, hepatic, haematological, immunological (other than RA), gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial. Patients with mild and stable asthma or mild and stable Chronic Obstructive Pulmonary Disease (COPD) may be included at the discretion of the Investigator
  • Active malignancy or lymphoproliferative disorder of any type, or a history of malignancy except for basal cell carcinoma of the skin that has been excised prior to the screening visit
  • Suspected alcohol or substance abuse
  • Donation of ≥ 400mL of blood within 8 weeks prior to baseline
  • Any other significant medical condition which in the opinion of the investigator might increase the risk to the patient or confound the interpretation of the data
  • Individuals who are legally institutionalised
  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: NCT00771420

Locations
Germany
Charite Research Organization GmbH
Berlin, Germany, 10117
Sponsors and Collaborators
MedImmune Ltd
Investigators
Study Director: Ehsanollah Esfandiari, PhD MD MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC ( MedImmune Ltd )
ClinicalTrials.gov Identifier: NCT00771420     History of Changes
Other Study ID Numbers: CAM-3001-0702
Study First Received: October 10, 2008
Last Updated: July 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014