N/A
Completed N=183
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
Source: ClinicalTrials.gov NCT01643928 ↗Enrolled (actual)
183
Serious AEs
6.9%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay — 3.5; 0.0; 15.2; 7.8 Percentage of Participants
Summary
This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay |
3.5; 0.0; 15.2; 7.8; 13.3; 6.7 | — |
| PRIMARY Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay |
3.5; 3.2; 15.2; 9.4; 10.0; 10.0 | — |
| PRIMARY Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay |
— | — |
| PRIMARY Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay |
— | — |
| PRIMARY Mean Rituximab Serum Trough Concentrations |
636.5; 855.5; 416.6; 1525.8; 980.0; 103019.3 | — |
| PRIMARY Cluster of Differentiation 19 (CD19+) B Cell Count |
0.0; 1.1; 0.6; 0.0; 0.6; 0.0 | — |
| PRIMARY Circulating Immunoglobulin G (IgG) Concentrations |
11.7; 10.9; 11.6; 11.3; 11.8; 10.4 | — |
| PRIMARY Circulating Immunoglobulin M (IgM) Concentrations |
1.0; 1.1; 1.1; 1.1; 1.0; 0.8 | — |
| PRIMARY Circulating Rheumatoid Factor (RF) Concentrations |
105.6; 431.3; 128.7; 75.2; 109.1; 56.1 | — |
| PRIMARY Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement |
293.7; 346.1; 311.5; 223.9; 306.1; 266.9 | — |
| PRIMARY Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 |
5.59; 5.81; 5.80; 6.16; 6.12; -1.24 | — |
| PRIMARY Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 |
5.59; 5.81; 5.77; 6.13; 6.10; -1.27 | — |
| PRIMARY Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 |
5.54; 5.81; 5.79; 6.14; 6.10; -1.25 | — |
| PRIMARY Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 |
13.7; 25.0; 32.3; 32.0; 21.4; 35.7 | — |
| PRIMARY Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 |
14.3; 26.9; 31.0; 29.2; 22.2; 37.7 | — |
| PRIMARY Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 |
15.9; 26.9; 28.6; 30.4; 22.2; 40.4 | — |
| PRIMARY Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 |
13.7; 25.0; 32.3; 32.0; 21.4; 35.7 | — |
| PRIMARY Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 |
14.3; 26.9; 31.0; 29.2; 22.2; 37.7 | — |
| PRIMARY Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 |
15.9; 26.9; 28.6; 30.4; 22.2; 40.4 | — |
| PRIMARY Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 |
3.9; 10.7; 19.4; 12.0; 7.1; 32.1 | — |
| PRIMARY Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 |
4.1; 11.5; 17.2; 12.5; 7.4; 34.0 | — |
| PRIMARY Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 |
4.5; 11.5; 14.3; 13.0; 7.4; 36.2 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 |
50.0; 59.4; 63.6; 66.7; 60.0; 66.7 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 |
51.9; 60.0; 64.5; 65.5; 62.1; 70.4 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 |
50.0; 60.0; 63.3; 70.4; 62.1; 70.8 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 |
17.2; 28.1; 48.5; 30.0; 30.0; 33.3 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 |
18.5; 26.7; 48.4; 27.6; 31.0; 35.2 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 |
18.8; 26.7; 46.7; 29.6; 31.0; 33.3 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 |
5.2; 12.5; 21.2; 16.7; 10.0; 21.1 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 |
5.6; 10.0; 19.4; 13.8; 10.3; 22.2 | — |
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 |
6.3; 10.0; 16.7; 14.8; 10.3; 22.9 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 |
-52.2; -57.1; -64.2; -57.0; -55.2; -41.4 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 |
-54.1; -56.0; -64.7; -55.5; -55.9; -42.7 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 |
-53.4; -56.0; -63.5; -59.6; -55.9; -41.5 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 |
-58.1; -54.2; -62.9; -54.9; -59.1; -51.7 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 |
-60.4; -52.5; -64.0; -53.3; -60.2; -55.1 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 |
-60.5; -52.5; -62.7; -53.9; -60.2; -55.6 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 |
-18.2; -36.3; -44.0; -38.8; -39.8; -31.9 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 |
-19.4; -34.9; -43.2; -37.1; -40.1; -33.2 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 |
-19.1; -34.9; -41.6; -38.2; -40.1; -31.8 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 |
-18.9; -43.8; -40.3; -45.1; -39.2; -34.6 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 |
-21.5; -41.7; -40.5; -43.8; -39.9; -37.4 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 |
-21.7; -41.7; -38.8; -44.4; -39.9; -36.9 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 |
-40.3; -46.1; -54.2; -55.0; -52.4; -60.4 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 |
-41.3; -45.4; -54.4; -54.0; -53.9; -62.1 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 |
-39.7; -45.4; -53.1; -55.6; -53.9; -62.8 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 |
-12.2; -31.0; -39.1; -28.8; -27.7; -20.0 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 |
-15.6; -29.3; -40.0; -26.7; -28.4; -23.4 | — |
| PRIMARY Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 |
-13.9; -29.3; -38.6; -26.7; -28.4; -23.1 | — |
| PRIMARY Outcome Measure Using HAQ-DI - by the End of Course 1 |
1.4; 1.1; 1.0; 1.2; 1.3; 1.3 | — |
| PRIMARY Outcome Measure Using HAQ-DI - by the End of Course 2 |
1.4; 1.2; 1.0; 1.3; 1.2; 1.3 | — |
| PRIMARY Outcome Measure Using HAQ-DI - by the End of Course 3 |
1.4; 1.2; 1.0; 1.3; 1.2; 1.2 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
Exclusion Criteria
- Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
- Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
Data sourced from ClinicalTrials.gov (NCT01643928). 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.