Phase 3
Completed N=100
A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01231321 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Mar 2011
Primary outcomePrimary: Frequency of Adverse Events — 38; 1; 1; 24 participants
Summary
A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events |
38; 1; 1; 24; 3; 0 | — |
| PRIMARY Changes of Physical Examination |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Deviation From Normal Laboratory Ranges |
0; 0; 0; 0; 17; 11 | — |
| PRIMARY Vital Sign Values |
1; 2; 0; 0; 0; 0 | — |
| SECONDARY Change in Disease Activity Score (DAS28) Compared With Baseline |
-2.74 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females >= 18 years of age.
- A negative pregnancy test (human chorionic gonadotropin in serum samples) for women of childbearing potential prior to start of study treatment.
- Female subject is either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
- Contraceptives (oral, parenteral, patch) for three months prior to study drug administration.
- A vasectomized partner.
- American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for at least 6 months.
- Subjects must meet the following three criteria:
- Disease Activity Score (28 joints) more or equal 3.2 (at Baseline only)
- At least 6 swollen joints out of the 66 assessed
- At least 8 tender joints out of the 68 assessed
- Subjects must have a C-reactive protein >= 1.5mg/dL or erythrocyte sedimentation rate >= 28 mm/1h.
- Unsatisfactory response or intolerance to prior disease modifying anti-rheumatic drugs (must have failed at least 1 disease modifying anti-rheumatic drug).
- Able and willing to administer subcutaneous injections.
- Able and willing to give written informed consent and to comply with the requirements of the study protocol.
- Documented negative purified protein derivative test, defined as 1.75 x the upper limit of normal.
- Serum total bilirubin >= 1.5 mg/dL (>= 26 micromol/L).
- Creatinine > 1.5 mg/dL (133 micromol/L) in subjects upper limit of normal range in subjects >= 65 years old.
- Positive Hepatitis B or C serology indicative of previous or current infections.
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Data sourced from ClinicalTrials.gov (NCT01231321). 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.