Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01242488
First received: November 15, 2010
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Biological: CDP6038
Biological: Tocilizumab (Actemra or RoActemra)
Other: Placebo sc
Other: Placebo iv
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American College of Rheumatology 20% response (ACR20) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 50% response (ACR50) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]
  • American College of Rheumatology 70% response (ACR70) rates for the CDP6038 and placebo arms. [ Time Frame: From Baseline to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242488

  Show 82 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01242488     History of Changes
Other Study ID Numbers: RA0056
Study First Received: November 15, 2010
Last Updated: January 25, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Rheumatoid Arthritis
CDP6038
Interleukin-6
Tocilizumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014