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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771420
• Other study ID #: CAM-3001-0702
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2008
• Last updated: July 19, 2012
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: July 2012
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.

Other:
• Placebo
Active: Placebo 5:1 for arms 2-6

Locations

Country	Name	City	State
Germany	Charite Research Organization GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values		End of study	Yes
Secondary	Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group:		Day 28 post infusion	No