Rheumatoid ArthritisPhase 1NCT00771420
A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis
A Phase 1 study testing CAM-3001 in people with Rheumatoid Arthritis, run by MedImmune Ltd at 1 site in Germany.
Trial summary
Investigate safety and tolerability of the escalating dose of CAM-3001 in patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CAM-3001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite Research Organization GmbH
Berlin, State of Berlin, 10117
About this study
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.
Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CAM-3001, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM-3001Drug
Also called Mavrilimumab
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-3001Drug
Also called Mavrilimumab
Dosed at 0.1mg/kg.
CAM-3001Drug
Also called Mavrilimumab
Dosed at 0.3mg/kg
CAM-3001Drug
Also called Mavrilimumab
Dosed at 1.0 mg/kg.
CAM-3001Drug
Also called Mavriliumab
Dosed at 3.0 mg/kg.
CAM-3001Drug
Also called Mavrilimumab
Dosed at 10 mg/kg.
PlaceboOther
Active: Placebo 5:1 for arms 2-6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 0.01mg/kg and 0.03mg/kg CAM-3001 Receives: Drug: CAM-3001 |
| 2 | Active comparator | 0.1mg/kg CAM-3001 Receives: Drug: CAM-3001 |
| 3 | Active comparator | 0.3mg/kg CAM-3001 Receives: Drug: CAM-3001 |
| 4 | Active comparator | 1.0mg/kg CAM-3001 Receives: Drug: CAM-3001 |
| 5 | Active comparator | 3.0mg/kgCAM-3001 Receives: Drug: CAM-3001 |
| 6 | Active comparator | 10.0mg/kg CAM-3001 Receives: Drug: CAM-3001 |
| 7 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values
Measured: End of study
Secondary outcomes (1)
Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group:
Measured: Day 28 post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ehsanollah Esfandiari, PhD MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771420
- Sponsor's protocol ID
- CAM-3001-0702
- Status last verified
- Jul 2012
- First submitted
- 10 Oct 2008
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21613310
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00771420
- Acronym / sponsor ID
- CAM-3001-0702
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- MedImmune LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate safety and tolerability of the escalating dose of CAM-3001 in patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CAM-30010.01mg/kg and 0.03mg/kg CAM-3001 |
| 2 | Active comparator | Drug: CAM-30010.1mg/kg CAM-3001 |
| 3 | Active comparator | Drug: CAM-30010.3mg/kg CAM-3001 |
| 4 | Active comparator | Drug: CAM-30011.0mg/kg CAM-3001 |
| 5 | Active comparator | Drug: CAM-30013.0mg/kgCAM-3001 |
| 6 | Active comparator | Drug: CAM-300110.0mg/kg CAM-3001 |
| 7 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAM-3001Also: MavrilimumabA 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. | Drug | 1 |
| CAM-3001Also: MavrilimumabDosed at 0.1mg/kg. | Drug | 2 |
| CAM-3001Also: MavrilimumabDosed at 0.3mg/kg | Drug | 3 |
| CAM-3001Also: MavrilimumabDosed at 1.0 mg/kg. | Drug | 4 |
| CAM-3001Also: MavriliumabDosed at 3.0 mg/kg. | Drug | 5 |
| CAM-3001Also: MavrilimumabDosed at 10 mg/kg. | Drug | 6 |
| PlaceboActive: Placebo 5:1 for arms 2-6 | Other | 7 |
Primary outcome
Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values
Time frame: End of study
1 secondary outcome
Pharmacokinetic parameters of CAM-3001 will be calculated and tabulated descriptively for each dose group:
Time frame: Day 28 post infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Derived from this study: PubMed 21613310Burmester 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehsanollah Esfandiari, PhD MD study director
MedImmune LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAM-3001 in people with Rheumatoid Arthritis, run by MedImmune Ltd at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events • Changes in vital signs, ECG, lung function tests and clinical laboratory values (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.