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

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID: NCT01500278
Run by: UCB Pharma SA
People needed: 915
Starts: 2011-12-01
Expected to finish: 2016-01-01
Last updated by the study team: 2018-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

214 — Tuscaloosa, Alabama, United States
159 — Tucson, Arizona, United States
152 — Hot Springs, Arkansas, United States
147 — Covina, California, United States
161 — Fullerton, California, United States
217 — La Mesa, California, United States
149 — Los Angeles, California, United States
144 — Menifee, California, United States
185 — Roseville, California, United States
208 — Sacramento, California, United States
189 — Van Nuys, California, United States
148 — Whittier, California, United States
220 — Lewes, Delaware, United States
142 — Aventura, Florida, United States
216 — Fort Lauderdale, Florida, United States
162 — Gainesville, Florida, United States
209 — Vero Beach, Florida, United States
145 — Coeur d'Alene, Idaho, United States
202 — Maywood, Illinois, United States
134 — Lexington, Kentucky, United States
178 — Baltimore, Maryland, United States
137 — Battle Creek, Michigan, United States
153 — Detroit, Michigan, United States
155 — Lansing, Michigan, United States
141 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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