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

NCT00771420 | Completed Phase 1 DMC

• 1 other identifier: CAM-3001-0702
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values

  End of study

Secondary Outcomes (1)

• Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group:

  Day 28 post infusion

Study Arms (7)

1

ACTIVE COMPARATOR

0.01mg/kg and 0.03mg/kg CAM-3001

Drug: CAM-3001

2

ACTIVE COMPARATOR

0.1mg/kg CAM-3001

Drug: CAM-3001

3

ACTIVE COMPARATOR

0.3mg/kg CAM-3001

Drug: CAM-3001

4

ACTIVE COMPARATOR

1.0mg/kg CAM-3001

Drug: CAM-3001

5

ACTIVE COMPARATOR

3.0mg/kgCAM-3001

Drug: CAM-3001

6

ACTIVE COMPARATOR

10.0mg/kg CAM-3001

Drug: CAM-3001

7

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CAM-3001 DRUG

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.

Also known as: Mavrilimumab

1

Placebo OTHER

Active: Placebo 5:1 for arms 2-6

7

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune Ltd: lead

Study Sites (1)

Charite Research Organization GmbH

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• Burmester GR, Feist E, Sleeman MA, Wang B, White B, Magrini F. Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-alpha, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis. 2011 Sep;70(9):1542-9. doi: 10.1136/ard.2010.146225. Epub 2011 May 25.

  PMID: 21613310 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

mavrilimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ehsanollah Esfandiari, PhD MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

DE (1)