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

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Pfizer

Status and phase

Completed
Phase 3

Conditions

Arthritis, Rheumatoid

Treatments

Drug: CP-690,550

Study type

Interventional

Funder types

Industry

Identifiers

NCT00413699
2006-005035-19 (EudraCT Number)
A3921024

Details and patient eligibility

About

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

Enrollment

4,488 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,488 participants in 2 patient groups

Open-Label Active Treatment Enrolled from Phase 2
Experimental group
Description:
Patients enrolling from Phase 2 studies
Treatment:
Drug: CP-690,550
Drug: CP-690,550
Open-Label Active Treatment Enrolled from Phase 3
Experimental group
Description:
Patients enrolling from Phase 3 studies
Treatment:
Drug: CP-690,550
Drug: CP-690,550

Trial contacts and locations

469

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Data sourced from clinicaltrials.gov

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