Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis - Full Text View

Purpose

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CP-690,550	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-Term, Open-Label Follow-Up Study Of Tofacitinib (CP-690,550) For Treatment Of Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Flu Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Primary endpoints will be standard laboratory safety data (chemistry, hematology, etc.) and adverse event (AE) reports [ Time Frame: Every visit until last observation ] [ Designated as safety issue: Yes ]
The long-term safety and tolerability of CP-690,550 5 mg BID and 10 mg BID for the treatment of rheumatoid arthritis [ Time Frame: Every visit until last observation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent of patients with ACR 20, 50, and 70 responses [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
Area under ACR n curve [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
DAS 28 (CRP) and DAS 28 (ESR)as well as incidence of Disease Activity Score <2.6 and <3.2 [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
HAQ DI score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
SF 36 score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
Preservation of joint structure in patients who had baseline radiographs obtained in their qualifying index study [ Time Frame: Every 6 months until last observation. ] [ Designated as safety issue: No ]
Vaccine sub-study endpoints: 1. % achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥ 2-fold increase in antibody concentrations [ Time Frame: at vaccine substudy vsisit 2 and 4 ] [ Designated as safety issue: No ]
Vaccine sub-study 2. % achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥ 4-fold increase in antibody titers [ Time Frame: at vaccine substudy visit 2 and 4 ] [ Designated as safety issue: No ]
1. Percentage of subjects achieving protective antibody titers to the seasonal influenza vaccine as measured by a hemagglutination inhibition (HI) assay titer of ≥ 1:40 in ≥ 2 of 3 influenza antigens measured at vaccine sub-study [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
visit 4. [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
2. Percentage of subjects who respond to each of the 12 pneumococcal antigens as defined by ≥ 2-fold increase in antibody concentrations from vaccine sub-study visit 2 (vaccination baseline) measured at vaccine sub-study visit 4. [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
3. Percentage of subjects who respond to each of the 3 influenza antigens as defined by ≥ 4-fold increase in antibody titers from vaccine sub-study visit 2 (vaccination baseline) measured at vaccine sub-study visit 4. [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
4. Fold increase of anti-pneumococcal antibody levels to each of the 12 pneumococcal antigens above vaccination baseline values (vaccine sub-study visit 2) at vaccine sub-study visit 4. [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
5. Fold increase of anti-influenza antibody levels to each of the 3 influenza antigens above vaccination baseline values (vaccine sub-study visit 2) at vaccine sub-study visit 4. [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
6. Concentrations of anti-pneumococcal antibodies at vaccine sub-study visit 3 and 4. [ Time Frame: at visit 3 and 4 ] [ Designated as safety issue: No ]
7. Titers of anti-influenza antibodies at vaccine sub-study visit 3 and 4. [ Time Frame: at visit 3 and 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Open-Label Active Treatment Enrolled from Phase 2 Patients enrolling from Phase 2 studies	Drug: CP-690,550 5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Experimental: Open-Label Active Treatment Enrolled from Phase 3 Patients enrolling from Phase 3 studies	Drug: CP-690,550 10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Vaccine sub-study visit

Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Exclusion Criteria:

Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Vaccine sub-study visit

Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
Received any vaccine within 1 month prior to randomization in this study
Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413699

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 438 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00413699 History of Changes
Other Study ID Numbers:	A3921024
Study First Received:	December 18, 2006
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

long-term
open-label
safety

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013