A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Inclusion Criteria:

1. Males and females >= 18 years of age.

2. A negative pregnancy test (human chorionic gonadotropin in serum samples) for women ofchildbearing potential prior to start of study treatment.

3. Female subject is either not of childbearing potential, defined as postmenopausal (atleast 1 year since last menses) or surgically sterile (bilateral tubal ligation,bilateral oophorectomy or hysterectomy), or is of childbearing potential andpracticing 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 drugadministration.

• A vasectomized partner.

4. American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for atleast 6 months.

5. 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

6. Subjects must have a C-reactive protein >= 1.5mg/dL or erythrocyte sedimentation rate >= 28 mm/1h.

7. Unsatisfactory response or intolerance to prior disease modifying anti-rheumatic drugs (must have failed at least 1 disease modifying anti-rheumatic drug).

8. Able and willing to administer subcutaneous injections.

9. Able and willing to give written informed consent and to comply with the requirementsof the study protocol.

10. Documented negative purified protein derivative test, defined as < 5 mm induration, orwillingness and ability to start tuberculosis prophylaxis before first dose of studydrug if the purified protein derivative result is positive and the chest X-ray is notsuggestive of active tuberculosis and there is no history of active tuberculosis.

Exclusion Criteria:

1. Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil withinat least 5 years before enrollment.

2. Prior treatment with intravenous immunoglobulin or any investigational agent "chemical" in nature within 30 days, or 5 half lives of the product, whichever islonger.

3. Prior treatment with cyclosporine within the last 6 months.

4. Prior treatment with investigational biologic therapy.

5. Subject has chronic arthritis diagnosis before the age 17 years.

6. Subject has undergone joint surgery within the preceding two months (at joints to beassessed within the study).

7. History of an allergic reaction or significant sensitivity to the constituents ofstudy drug (adalimumab).

8. Treatment within the last 2 months with approved biologic therapy (e.g. infliximab)prior to Baseline.

9. Prior treatment with total lymphoid irradiation.

10. History of cancer or lymphoproliferative disease other than a successfully andcompletely treated non-metastatic cutaneous squamous cell or basal cell carcinomaand/or localized carcinoma in situ of the cervix.

11. History of or current acute inflammatory joint disease of origin other than rheumatoidarthritis, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.

12. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heartfailure (New York Heart Association III-IV), active peptic ulcer disease, recentstroke (within 3 months) and any other condition which, in the opinion of theinvestigator, would put the subject at risk by participation in the protocol.

13. Subject is known to have immune deficiency, history of positive human immunodeficiencyvirus status or is immunocompromised.

14. Persistent chronic infection, or severe infections requiring hospitalization ortreatment with intravenous antibiotics within 30 days, or oral antibiotics within 14days prior to enrollment.

15. Female subjects who are pregnant or breast-feeding or is considering becoming pregnantduring the study or for 150 days after the last dose of study medication.

16. History of clinically significant drug or alcohol abuse in the last year.

17. Previous diagnosis or signs of central nervous system demyelinating diseases.

18. History of untreated or active tuberculosis, histoplasmosis or listeriosis.

19. History of clinically significant hematologic (e.g. severe anemia, leucopenia,thrombocytopenia), renal or liver disease (e.g. fibrosis, cirrhosis, hepatitis).

20. Screening clinical laboratory analysis showing any of the following abnormallaboratory results:

• Aspartate transaminase or alanine transaminase > 1.75 x the upper limit ofnormal.

• Serum total bilirubin >= 1.5 mg/dL (>= 26 micromol/L).

• Creatinine > 1.5 mg/dL (133 micromol/L) in subjects < 65 years old and > upperlimit of normal range in subjects >= 65 years old.

• Positive Hepatitis B or C serology indicative of previous or current infections.

21. Subject is considered by the Investigator, for any reason, to be an unsuitablecandidate for the study.