A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis
NCT ID: NCT00771420
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2008-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
0.01mg/kg and 0.03mg/kg CAM-3001
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.
2
0.1mg/kg CAM-3001
CAM-3001
Dosed at 0.1mg/kg.
3
0.3mg/kg CAM-3001
CAM-3001
Dosed at 0.3mg/kg
4
1.0mg/kg CAM-3001
CAM-3001
Dosed at 1.0 mg/kg.
5
3.0mg/kgCAM-3001
CAM-3001
Dosed at 3.0 mg/kg.
6
10.0mg/kg CAM-3001
CAM-3001
Dosed at 10 mg/kg.
7
Placebo
Placebo
Active: Placebo 5:1 for arms 2-6
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
CAM-3001
Dosed at 0.1mg/kg.
CAM-3001
Dosed at 0.3mg/kg
CAM-3001
Dosed at 1.0 mg/kg.
CAM-3001
Dosed at 3.0 mg/kg.
CAM-3001
Dosed at 10 mg/kg.
Placebo
Active: Placebo 5:1 for arms 2-6
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ehsanollah Esfandiari, PhD MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Charite Research Organization GmbH
Berlin, State of Berlin, Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAM-3001-0702
Identifier Type: -
Identifier Source: org_study_id