Trial record 1 of 2 for:
NCT01242488
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01242488 |
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Recruitment Status :
Completed
First Posted : November 17, 2010
Last Update Posted : August 27, 2014
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Brief Summary:
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis | Biological: CDP6038 Biological: Tocilizumab (Actemra or RoActemra) Other: Placebo sc Other: Placebo iv | Phase 2 |
CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week, randomized, double-blind, placebo- and active- controlled study comparing several doses and dosage regimens (every 2 weeks and every 4 weeks) of CDP6038 to placebo and tocilizumab in patients with active rheumatoid arthritis who have had an unsuccessful response to methotrexate and previous anti-TNF therapy. The study will test if CDP6038 is more efficacious than placebo in reducing the signs and symptoms of rheumatoid arthritis at 12 weeks while maintaining an adequate safety profile. In order to maintain the study blinding all subjects will be given a subcutaneous (sc) injection (under the skin) every 2 weeks, as well as an intravenous (iv) infusion every 4 weeks. In addition subjects must remain on stable weekly doses of methotrexate. Assessments during the study include evaluations of joint pain and swelling, laboratory blood and urine tests, physical examinations, vital signs, electrocardiograms, and questionnaires. Subjects who complete the 12-week study will be eligible to enroll in a long-term extension study receiving CDP6038.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 221 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | June 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Rheumatoid arthritis
| Arm | Intervention/treatment |
|---|---|
| Experimental: CDP6038 60 mg sc every 2 weeks plus methotrexate |
Biological: CDP6038
60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Experimental: CDP6038 60 mg sc every 4 weeks plus methotrexate |
Biological: CDP6038
60 mg sc at Weeks 0, 4 and 8 Other: Placebo sc 0.9% Sodium chloride for injection at Weeks 2, 6 and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Experimental: CDP6038 120 mg sc every 2 weeks plus methotrexate |
Biological: CDP6038
120 mg sc at Weeks 0, 2, 4 6, 8, and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Experimental: CDP6038 120 mg sc every 4 weeks plus methotrexate |
Biological: CDP6038
120 mg sc at Weeks 0, 4 and 8 Other: Placebo sc 0.9% Sodium chloride for injection at Weeks 2, 6 and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Experimental: CDP6038 240 mg sc every 2 weeks plus methotrexate |
Biological: CDP6038
240 mg sc at Weeks 0, 2, 4 6, 8, and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Experimental: CDP6038 240 mg sc every 4 weeks plus methotrexate |
Biological: CDP6038
240 mg sc at Weeks 0, 4 and 8 Other: Placebo sc 0.9% Sodium chloride for injection at Weeks 2, 6 and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Active Comparator: Tocilizumab 8 mg/kg iv every 4 weeks plus methotrexate |
Biological: Tocilizumab (Actemra or RoActemra)
8 mg/kg intravenously (iv) at Weeks 0, 4 and 8 Other: Placebo sc 0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10 |
| Placebo Comparator: Placebo sc every 2 weeks plus methotrexate |
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
| Placebo Comparator: Placebo sc every 4 weeks plus methotrexate |
Other: Placebo sc
0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10 Other: Placebo iv 0.9% Sodium chloride for injection at Weeks 0, 4 and 8 |
Primary Outcome Measures :
- Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo [ Time Frame: Baseline, Week 12 ]
Secondary Outcome Measures :
- American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ]
- American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ]
- American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
- Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to < 12.5mg/week are allowed if there is documented intolerance
- Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
- CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
- Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening
Exclusion Criteria:
- Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
- Wheelchair bound or bedridden.
- Disease modifying antirheumatic drugs (DMARDs) other than MTX.
- Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
- Treatment with other biologics within 4-24 weeks (depending on the biologic)
- History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
- Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
- Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
- Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
- History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242488
Locations
Show 82 study locations
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT01242488 |
| Other Study ID Numbers: |
RA0056 2010-020839-39 ( EudraCT Number ) |
| First Posted: | November 17, 2010 Key Record Dates |
| Last Update Posted: | August 27, 2014 |
| Last Verified: | January 2013 |
Keywords provided by UCB Pharma:
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Rheumatoid Arthritis CDP6038 Interleukin-6 Tocilizumab |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |