Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00674362
• Date of registration: 05/05/2008
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma
• Public title: Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study CERTAIN
• Scientific title: A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
• Date of first enrolment: June 2008
• Target sample size: 194
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00674362
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Austria, France, Germany, Italy, Poland

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
months and not longer than 10 years

Exclusion Criteria:

- All the concomitant diseases or pathological conditions that could interfere and
impact the assessment of the study treatment, or with the safety of the patient

- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial

- Patients must not have received any previous biological therapy for rheumatoid
arthritis (RA)



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Placebo

Biological: Certolizumab pegol

Primary Outcome(s)

Clinical Disease Activity Index (CDAI) Remission (=2.8) at Both Week 20 and Week 24 [Time Frame: Week 20 and Week 24]

Secondary Outcome(s)

Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24 [Time Frame: Baseline, Week 24]

Simplified Disease Activity Index (SDAI) Remission (=3.3) at Both Week 20 and Week 24 [Time Frame: Week 20 and Week 24]

Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits [Time Frame: Week 24 up to Week 52]

American College of Rheumatology 20% (ACR20) Response at Week 24 [Time Frame: Baseline, Week 24]

American College of Rheumatology 50% (ACR50) Response at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 [Time Frame: Baseline, Week 24]

Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits [Time Frame: Week 24 up to Week 52]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24 [Time Frame: Baseline, Week 24]

28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24 [Time Frame: Week 20 and Week 24]

Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24 [Time Frame: Baseline, Week 24]

American College of Rheumatology 70% (ACR70) Response at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Fatigue Assessment Scale at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24 [Time Frame: Baseline, Week 24]

Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24 [Time Frame: Baseline, Week 24]

Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits [Time Frame: Week 24 up to Week 52]

Secondary ID(s)

2007-000828-40

C87076

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/01/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00674362