ArthritisPhase 1/2NCT01009242
To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate
A Phase 1/2 study testing CDP6038, CDP 6038 SC and Methotrexate in people with Arthritis and Rheumatoid Arthritis, run by UCB Pharma at 6 sites in 2 countries.
Trial summary
The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid Arthritis
- What is being tested?
- CDP6038, CDP 6038 SC and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2009to Sep 2010
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA > 6 months duration on stable Methotrexate
- ≤9 swollen and ≤9 tender joints (28 joint count)
- Minimum Screening CRP of 0.5mg/L
Who cannot join
- Participation in previous studies with defined agents and durations
- Previous treatment with defined agents and durations
- Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
- Pregnancy
- Positive tests/signs of possible latent/active tuberculosis
- Positive HIV
- Drug addiction or alcohol abuse
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
San Antonio, Texas
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate
The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.
Read the detailed description
The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.
- Conditions
- Arthritis, Rheumatoid Arthritis
- Being tested
- CDP6038, Placebo IV, Placebo SC, CDP 6038 SC, Methotrexate
- Keywords
- CDP6038
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDP6038Biological
Single dose:
1 mg/kg CDP6038 IV
CDP6038Biological
Single dose:
0.1mg/kg CDP6038 IV
CDP6038Biological
Single dose:
1.0mg/kg CDP6038 SC
Placebo IVOther
Single dose:
Placebo IV
Placebo SCOther
Single dose:
Placebo SC
CDP 6038 SCDrug
Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo
MethotrexateDrug
Individual stable doses of methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV | Experimental | Cohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV. Receives: Biological: CDP6038; Other: Placebo IV; Drug: Methotrexate |
| 1 mg/kg CDP6038 SC and Placebo SC | Experimental | Cohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc. Receives: Biological: CDP6038; Other: Placebo SC; Drug: Methotrexate |
| Optimized CDP6038 SC | Experimental | Cohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo. Receives: Drug: CDP 6038 SC; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
Measured: For 12 weeks following single dose
Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
Measured: For 12 weeks following single dose
Secondary outcomes (3)
Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion
Measured: For 12 weeks following single dose
Assess the immunogenicity of single dose CDP6038
Measured: Multiple sampling from 0 to 12 weeks following single dose
Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA
Measured: For 12 weeks following single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009242
- Sponsor's protocol ID
- RA0010
- Other IDs
- 2009-010813-57, 2009
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2009
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate
- ClinicalTrials.gov ID
- NCT01009242
- Acronym / sponsor ID
- RA0010
- Conditions
- Arthritis, Rheumatoid Arthritis
- Keywords
- CDP6038
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Nov 2009 (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.
The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.
Detailed description
The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV | Experimental | Biological: CDP6038, Other: Placebo IV, Drug: MethotrexateCohort 1, Group 1 will compare 0.1mg/kg, 1mg/kg CDP6038 and placebo IV. |
| 1 mg/kg CDP6038 SC and Placebo SC | Experimental | Biological: CDP6038, Other: Placebo SC, Drug: MethotrexateCohort 1, Group 2 will compare 1mg/kg CDP6038 and placebo sc. |
| Optimized CDP6038 SC | Experimental | Drug: CDP 6038 SC, Drug: MethotrexateCohort 2, Group 3 will compare optimized sc doses of CDP6038 based on outcome of Cohort 1 with placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- RA > 6 months duration on stable Methotrexate
- ≤9 swollen and ≤9 tender joints (28 joint count)
- Minimum Screening CRP of 0.5mg/L
Key exclusion criteria (7 listed)
- Participation in previous studies with defined agents and durations
- Previous treatment with defined agents and durations
- Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
- Pregnancy
- Positive tests/signs of possible latent/active tuberculosis
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 |
|---|---|---|
| CDP6038Single dose: 1 mg/kg CDP6038 IV | Biological | 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV |
| CDP6038Single dose: 0.1mg/kg CDP6038 IV | Biological | 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV |
| CDP6038Single dose: 1.0mg/kg CDP6038 SC | Biological | 1 mg/kg CDP6038 SC and Placebo SC |
| Placebo IVSingle dose: Placebo IV | Other | 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV |
| Placebo SCSingle dose: Placebo SC | Other | 1 mg/kg CDP6038 SC and Placebo SC |
| CDP 6038 SCOptimized CDP6038 SC doses based on outcome of Cohort 1 with placebo | Drug | Optimized CDP6038 SC |
| MethotrexateIndividual stable doses of methotrexate. | Drug | 0.1mg/kg and 1mg/kg CDP6038 IV and Placebo IV, 1 mg/kg CDP6038 SC and Placebo SC, Optimized CDP6038 SC |
Primary outcome
PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
Time frame: For 12 weeks following single dose
Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
Time frame: For 12 weeks following single dose
3 secondary outcomes
Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion
Time frame: For 12 weeks following single dose
Assess the immunogenicity of single dose CDP6038
Time frame: Multiple sampling from 0 to 12 weeks following single dose
Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA
Time frame: For 12 weeks following single dose
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 15 Nov 2024.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CDP6038, CDP 6038 SC and Methotrexate in people with Arthritis and Rheumatoid Arthritis, run by UCB Pharma at 6 sites in 2 countries.
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 3 inclusion and 7 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 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PK/PD relationship between systemic CDP6038 exposure and CRP suppression. (time frame: For 12 weeks following single dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.