Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01500278
• Date of registration: 22/12/2011
• Prospective Registration: No
• Primary sponsor: UCB Pharma SA
• Public title: Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
• Scientific title: A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate
• Date of first enrolment: December 2011
• Target sample size: 915
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01500278
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Australia, Austria, Bulgaria, Canada, Czech Republic, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Monaco, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by
the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology
(ACR) classification criteria (Aletaha D et al, 2010)

- Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic
Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at
Screening

- Subject must have moderate to severe RA disease at Screening and Baseline defined as:

1. Screening (all criteria required)

- = 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2

- C-Reactive Protein (CRP) concentration = 10 mg/L (or 1.0 mg/dL) or
Erythrocyte Sedimentation Rate (ESR) (Westergren) = 28 mm/hr

2. Baseline (both criteria required)

- = 4 swollen joints (of 28 prespecified joints)

- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2

- Subject must have inadequately responded previously to Methotrexate (MTX)

- Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has
used the same MTX regimen for a minimum of 28 days prior to Baseline

Exclusion Criteria:

- Subject has previously received any biological Disease Modifying Antirheumatic Drug
(DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase,
phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine
kinase

- Diagnosis of any other inflammatory arthritis

- Infected with Tuberculosis (TB) or high risk of acquiring TB infection

- Subjects with concurrent acute or chronic viral hepatitis B or C infection

- Subjects with a history of chronic or recurrent infections or subjects at high risk of
infection

- Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological
DMARDs excluding study medications, experimental therapy, IA hyaluronic acid



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Adalimumab (ADA)

Biological: Certolizumab Pegol (CZP)

Drug: Methotrexate (MTX)

Primary Outcome(s)

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104 [Time Frame: Week 104]

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104 [Time Frame: From Baseline to Week 104]

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 12 [Time Frame: Week 12]

Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104 [Time Frame: Week 104]

Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12 [Time Frame: Week 104]

Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12 [Time Frame: From Week 12 up to Week 104]

Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 6 [Time Frame: Week 6]

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6 [Time Frame: Week 6]

Secondary ID(s)

RA0077

2011-002067-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel

Results

• Results available: Yes
• Date Posted: 31/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01500278