Summary of the study designs, patients, and treatments for the RCTs included in the post hoc analysis.
| ClinicalTrials.gov Identifier | Study Name/Protocol No. | Total No. of Patients Treated, N | Patient Population | Randomization and Interventions | Study Duration, Months |
|---|---|---|---|---|---|
| Placebo-controlled cohort (phase III studies) | |||||
| NCT0084761317,20 | ORAL Scan, A3921044 | 797 | Aged ≥ 18 yrs with a diagnosis of active RAa and an inadequate response to MTX | Patients were randomized 4:4:1:1 to receive 1 of the following with background MTX: TOF 5 mg BID TOF 10 mg BID Placebo advanced to TOF 5 mg BIDb Placebo advanced to TOF 10 mg BIDb | 24 |
| NCT0085338519 | ORAL Standard, A3921064 | 717 | Aged ≥ 18 yrs with a diagnosis of active RAa and an inadequate response to MTX | Patients were randomized 4:4:4:1:1 to receive 1 of the following with background MTX: TOF 5 mg BID TOF 10 mg BID ADA 40 mg Q2W Placebo advanced to TOF 5 mg BIDb Placebo advanced to TOF 10 mg BIDb | 12 |
| NCT0085654416 | ORAL Sync, A3921046 | 792 | Aged ≥ 18 yrs with a diagnosis of active RAc and an inadequate response to ≥ 1 nonbiologic or biologic DMARDs | Patients were randomized 4:4:1:1 to receive 1 of the following with background csDMARDs: TOF 5 mg BID TOF 10 mg BID Placebo advanced to TOF 5 mg BIDb Placebo advanced to TOF 10 mg BIDb | 12 |
| Head-to-head cohort (phase IIIb/IV study) | |||||
| NCT0218705521 | ORAL Strategy, A3921187 | 1146 | Aged ≥ 18 yrs with a diagnosis of active RAd and an inadequate response to MTX | Patients were randomized 1:1:1 to receive 1 of the following: TOF 5 mg BID monotherapy TOF 5 mg BID with background MTX ADA 40 mg Q2W with background MTX | 12 |
↵aBased on the ACR 1987 revised criteria.26 Active disease was defined as ≥ 6 tender/painful joints (68-joint count) and ≥ 6 swollen joints (66-joint count), and by an ESR (Westergren method) > 28 mm/h or a CRP level of > 7 mg/L (reference range 0–10 mg/L).
↵bAt month 3, placebo nonresponders (ie, those not achieving ≥ 20% reduction from baseline in SJC and TJC) were advanced in a blinded manner to TOF 5 or 10 mg BID. At month 6, all remaining placebo-treated patients were advanced to TOF.
↵cBased on the ACR 1987 revised criteria.26 Active disease was defined as ≥ 4 tender/painful joints on motion (28-joint count) and ≥ 4 swollen joints (28-joint count), and by an ESR (Westergren method) > 28 mm/h or a CRP level > 66.7 nmol/L.
↵dBased on the 2010 ACR and EULAR classification criteria.27 Active disease was defined as ≥ 4 tender/painful joints on motion (28-joint count) and ≥ 4 swollen joints (28-joint count) at baseline, despite treatment with MTX 15–25 mg/week, high-sensitivity CRP ≥ 3 mg/L in a central laboratory, and class I–III functional capacity as classified by the ACR 1991 revised criteria for global functioning status in RA.28 ACR: American College of Rheumatology; ADA: adalimumab; CRP: C-reactive protein; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DMARD: disease-modifying antirheumatic drug; ESR: erythrocyte sedimentation rate; EULAR: European Alliance of Associations for Rheumatology; MTX: methotrexate; Q2W: once every 2 weeks; RA: rheumatoid arthritis; RCT: randomized controlled trial; SJC: swollen joint count; TJC: tender joint count; TOF: tofacitinib.