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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00413699
First received: December 18, 2006
Last updated: June 26, 2014
Last verified: June 2014

December 18, 2006
June 26, 2014
February 2007
November 2019   (final data collection date for primary outcome measure)
  • 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 ]
The long-term safety and tolerability of CP-690,550 5 mg BID for the treatment of rheumatoid arthritis
Complete list of historical versions of study NCT00413699 on ClinicalTrials.gov Archive Site
  • 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 visit 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 ]
  • 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 ]
ACR 20, 50 and 70 response rates at 3, 6, 9 and 12 months; DAS 28-3(CRP) and quality of life assessments at multiple timepoints throughout the course of the study
Not Provided
Not Provided
 
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
A Long-Term, Open-Label Follow-Up Study Of Tofacitinib (CP-690,550) For Treatment Of Rheumatoid Arthritis

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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.
  • 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.
  • Experimental: Open-Label Active Treatment Enrolled from Phase 2
    Patients enrolling from Phase 2 studies
    Intervention: Drug: CP-690,550
  • Experimental: Open-Label Active Treatment Enrolled from Phase 3
    Patients enrolling from Phase 3 studies
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4385
November 2019
November 2019   (final data collection date for primary outcome measure)

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

  1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
  2. Received any vaccine within 1 month prior to randomization in this study
  3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Costa Rica,   Croatia,   Czech Republic,   Denmark,   Dominican Republic,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom
 
NCT00413699
A3921024
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP