Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00234845 |
Recruitment Status :
Completed
First Posted : October 10, 2005
Last Update Posted : August 29, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: adalimumab Drug: methotrexate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 148 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis |
Study Start Date : | March 2003 |

- Job loss measurement
- Job productivity measurements
- Patient reported outcomes
- DAS28
- Safety parameters

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
- Subject must be in paid employment
- Subject has self-reported work impairment since onset of symptoms
Exclusion Criteria:
- A subject has chronic arthritis diagnosed before age 16 years.
- Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs
- Subject has preceding treatment with any biological TNF antagonist
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234845
United States, Illinois | |
Global Medical Information - Abbott | |
Abbott Park, Illinois, United States, 60064 |
Study Director: | Beverly Paperiello | Abbott |
ClinicalTrials.gov Identifier: | NCT00234845 |
Other Study ID Numbers: |
M02-527 |
First Posted: | October 10, 2005 Key Record Dates |
Last Update Posted: | August 29, 2007 |
Last Verified: | August 2007 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |