Phase 4
Completed N=915
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
Source: ClinicalTrials.gov NCT01500278 ↗Enrolled (actual)
915
Serious AEs
12.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12 — 69.2; 71.4 Percentage of subjects — p==0.467
◆ Published Evidence
Highly cited
179citations · ~18 / year
Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study.
Summary
This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.
Linked Publications (3)
-
Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study.
-
Impact of high rheumatoid factor levels on treatment outcomes with certolizumab pegol and adalimumab in patients with rheumatoid arthritis.
-
Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12 |
69.2; 71.4 | =0.467 |
| PRIMARY Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104 |
35.5; 33.5 | =0.532 |
| SECONDARY Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104 |
45.6; 42.4 | — |
| SECONDARY Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6 |
64.5; 60.8 | — |
| SECONDARY Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6 |
20.5; 18.1 | — |
| SECONDARY Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 |
30.4; 29.7 | — |
| SECONDARY 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 |
47.7; 46.6 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104 |
-0.62; -0.72 | — |
| SECONDARY Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12 |
0; 0.0028; 0.0198; 0.0332; 0.0453; 0.0609 | — |
Eligibility 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:
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01500278) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.