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

July 19, 2012 updated by: MedImmune Ltd

A Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charite Research Organization GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Active Comparator: 2
0.1mg/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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Active Comparator: 3
0.3mg/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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Active Comparator: 4
1.0mg/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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Active Comparator: 5
3.0mg/kgCAM-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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Active Comparator: 6
10.0mg/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 Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.1mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 0.3mg/kg
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 1.0 mg/kg.
Other Names:
  • Mavrilimumab
Drug: CAM-3001
Dosed at 3.0 mg/kg.
Other Names:
  • Mavriliumab
Drug: CAM-3001
Dosed at 10 mg/kg.
Other Names:
  • Mavrilimumab
Placebo Comparator: 7
Placebo
Other: Placebo
Active: Placebo 5:1 for arms 2-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values
Time Frame: End of study
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group:
Time Frame: Day 28 post infusion
Day 28 post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune Ltd

Investigators

  • Study Director: Ehsanollah Esfandiari, PhD MD, MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM-3001-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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