A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Drug: CP-690-550
Drug: Placebo
Drug: Adalimumab
Drug: CP-690,550

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550446
A3921035

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Enrollment

386 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must have active rheumatoid arthritis
  • Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
  • Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion criteria

  • Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
  • Subjects who previously received adalimumab (Humira®) therapy for any reason.
  • Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

386 participants in 7 patient groups, including a placebo group

1
Active Comparator group
Treatment:
Drug: Adalimumab
2
Experimental group
Treatment:
Drug: CP-690-550
3
Experimental group
Treatment:
Drug: CP-690-550
4
Experimental group
Treatment:
Drug: CP-690-550
5
Experimental group
Treatment:
Drug: CP-690,550
6
Experimental group
Treatment:
Drug: CP-690,550
7
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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