Phase 3
Completed N=168
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT00753454 ↗Enrolled (actual)
168
Serious AEs
3.0%
Results posted
Jun 2012
Primary outcomePrimary: Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period — 52.4 percentage of subjects
Summary
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period |
52.4 | — |
| PRIMARY Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period |
2.4 | — |
| PRIMARY Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period |
3.0 | — |
| SECONDARY Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit |
73.5 | — |
| SECONDARY Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit |
59.4 | — |
| SECONDARY Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit |
39.4 | — |
| SECONDARY Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit |
-2.94 | — |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit |
-29.14 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit |
-28.26 | — |
| SECONDARY Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit |
32.9 | — |
| SECONDARY Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit |
31.1 | — |
| SECONDARY Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit |
30.3 | — |
| SECONDARY Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit |
-0.67 | — |
| SECONDARY Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit |
-2.58 | — |
| SECONDARY Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
9.04 | — |
| SECONDARY Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
10.32 | — |
| SECONDARY Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
12.73 | — |
| SECONDARY Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
5.1 | — |
| SECONDARY Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
10.27 | — |
| SECONDARY Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
8.54 | — |
| SECONDARY Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
7 | — |
| SECONDARY Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit |
5.57 | — |
| SECONDARY Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit |
10.73 | — |
| SECONDARY Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit |
5.82 | — |
| SECONDARY Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit |
-36.04 | — |
| SECONDARY Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit |
-35.51 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be able to understand the written Informed Consent Form (ICF)
- Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
- Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
- Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
- Patients must be willing to comply with protocol
Exclusion Criteria
- Patients must not have a diagnosis of any other inflammatory Arthritis
- Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
- Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
- Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
Data sourced from ClinicalTrials.gov (NCT00753454). 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.